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Quality & Regulatory

Quality is part of our culture at FHC.  Our Quality System is designed to support our mission to collaborate with our customers to develop and market innovative neurological research, surgical, and therapeutic equipment crafted to be the world’s finest.  We have established and maintain a continually improving quality system based on ISO 13485, the Canadian Medical Devices Regulation (CMDR), the Medical Device Directive (MDD) in Europe and the FDA Quality System Regulations.  Our quality system documents all the processes and procedures we follow to design, develop, manufacture and ship quality products to satisfy our customers’ needs.

Key Certifications and Capabilities include:

ISO 13485;2016 and MDSAP
FDA 510(k) Clearance microTargeting Electrodes
FDA 510(k) Clearance Guideline 4000
FDA 510(k) Clearance Guideline 4000 5.0
FDA 510(k) Clearance microTargeting Drive System
FDA 510(k) Clearance microTargeting Drive System Accessories
FDA 510(k) Clearance microTargeting STar Drive System
FDA 510(k) Clearance WayPoint Stereotactic System
FDA 510(k) Clearance Microtable Stereotactic System
EC Certificate EC Design-Examination Certificate Electrodes and Tubes
EC Certificate Full Quality Assurance System Electrodes and Tubes
EC Certificate for WayPoint Stereotactic System, microTargeting Guideline 4000, Electrode Cable, & Sterile Drapes
Health Canada Medical Device License microNeurography Needle Electrode
Health Canada Medical Device License microTargeting Drive Syatem & Electrodes
Health Canada Medical Device License Guideline 4000
Health Canada Medical Device License microTargeting Guideline 4000 5.0
Health Canada Medical Device License microTargeting STar Drive System
Health Canada Medical Device License WayPoint Stareotactic System
Health Canada Medical Device License Digital Display Unit (DDU) for use with Nexdrive by Medtronic
Regulatory Certifications LP+ Mexico
Regulatory Certifications STar Drive Mexico
Regulatory Certifications WayPoint Sterreotactic System Saudi Arabia
Regulatory Certifications Electrodes Saudi Arabia
Regulatory Certifications STar Drive Saudi Arabia
Regulatory Certificate Registration Colombia
Regulatory Certifications MSACert Japan
ARTG Certificate Guideline Australia
ARTG Certificate Sterile Insertion tubes Australia
ARTG Certificate Non-sterile Insertion tubes Australia
ARTG Certificate WayPoint Australia
ARTG Certificate Electrodes Australia
ARTG Certificate Drive System Australia
ARTG Certificate Sterile Drapes Australia
ARTG Certificate Sterile Cables Australia

Please contact Kelly Moeykens or Pooja Rathor if the document you are looking for is not listed above.  We would be pleased to speak with you. Kelly may be reached by calling 207-666-5651 x2195 or e-mail kmoeykens@fh-co.com. Pooja may be reached at 207-666-5651 x2252 or prathor@fh-co.com.

If you need to submit a Product Information Report, please download and complete the form and then fax or submit it to FHC Customer & Technical Support using the form below.

Download Report

Fax Number: 207-666-8292

California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm.

Ethelene Oxide is on the list of chemicals in Prop. 65.

The products included in this list are sterilized using EO and have residual levels of EO that are higher than what is allowed per PROP 65, therefore the following warning is required:

⚠ WARNING: This product can expose you to chemicals including Ethylene Oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm.  For more information, go to www.P65Warnings.ca.gov.

 

Part ID Description Sterile
C0230 Guideline 5 3m uE Lead Cable YES
C0231 Guideline 5 1.5m uE Lead Cable YES
22375Z Sterile DZap Tungsten Short Profile YES
22670 Box of 5 array electrodes YES
22670R Array Electrode/Sterile 5pk YES
22675L Array DZAP Leadpoint/Sterile YES
22675Z Array DZAP/Sterile 5pk YES
34680 Box of 5 single electrodes YES
34680R Single Electrode Sterile/5pk YES
34685L Single DZap Leadpoint/  Sterile 5pk YES
34685Z Single DZap / Sterile 5pk YES
44970R Platform Array Sterile/5pk YES
44975L Platform Array Dzap Leadpoint YES
44975Z Platform Array Dzap Sterile YES
5000R Nexframe / Array Sterile / 5pk YES
5005L Nexframe / DZap Leadpoint / Array Sterile/ 5pk YES
5005Z Nexframe / DZap Array Sterile/ 5pk YES
5700R Nexframe / Array Sterile / 5pk YES
5705L Nexframe / DZap Leadpoint STar Drive Sterile/ 5pk YES
5705Z Nexframe / DZap/ STar Drive Sterile/ 5pk YES
66-AC-DC LeadLoc Depth Stop, Sterile YES
66-EL-EC mTargeting Electrode Cable YES
66-EL-EC-01 mT Electrode Cable w/ Alligator Clips YES
66-EL-LP Patient Lead for LP+ YES
66-IT-01P 5x Sterile Single IT Set YES
66-IT-03P 5x Sterile Single IT Set YES
66-IT-05P 5x Sterile Single IT Set YES
66-IT-07P 5x Sterile Single IT Set YES
66-IT-08P 5x Sterile Single IT Set YES
66-IT-09P 5x Sterile Single IT Set YES
66-IT-1018 Sterile Array Insertion Tube YES
66-IT-1019 Sterile Lead Insertion Tube YES
66-IT-1028 28 cm Lead Insertion Tube YES
66-IT-13P Ster. Insertion Tube Set 5x YES
66-IT-14P 5x Sterile Single IT Set YES
66-IT-14S Stereotactic Frame Insertion Tube Set 5x YES
66-IT-3000 Box 5 Single Insertion Tubes YES
66-IT-4000 Box of 5 Insertion Tubes YES
66-IT-4015 Single Electrode Insertion Tube Set 15mm above target 5x YES
66-IT-4015S NexFrame® Insertion Tube Kit 5x YES
66-IT-40L D.Zap Single Insertion YES
66-IT-7100 Array Insertion Elect/Tube YES
66-IT-7140LI Array Lead Insert Tubesw/Sty YES
66-IT-AO1P IT/Stylet 162mm Sterile 5pk YES
66-IT-AR14P mT Lead Insertion Tube w/ Stylet YES
66-IT-AR21P Array Lead Insertion Tube w/ Stylet YES
66-IT-AR27P mT Lead Insertion Tube w/ Stylet YES
66-IT-AR30P Array Lead Insertion Tube w/ Stylet YES
66-IT-AR41P microTargeting Insertion Tube w/Stylet YES
66-IT-AR42P Array Insertion Tube w/Stylet 5x YES
66-IT-AR43P Array Lead Insertion Tube w/Stylet 5x YES
66-IT-AR4P microTargeting Lead Insertion YES
66-IT-AR5P microTargeting Array Insertion YES
66-IT-AR6P mT Lead Insertion Tube w/ Stylet YES
66-IT-BP8P microTargeting Insertion YES
66-IT-DB11P microTargeting Single Ins. YES
66-IT-DB12P Single Insertion Tube with Stylet At Target YES
66-IT-DB9P microTargeting Single Insertion Tube YES
66-IT-DV1P 5x Sterile Single IT Set YES
66-IT-FPP Sterile Tandem Insertion Tube Set 5/pk YES
66-IT-KH1P Nexframe/Nexdrive IT Set YES
66-IT-NX1P 5x Sterile Array IT Set YES
66-ST-14P DP Stylet 5x 204 mm YES
66-WP-BKS Bilateral Surgical Kit YES
66-WP-IKS WayPoint Implant Kit YES
66-WP-SKS WayPoint Platform Surgical Kit YES
70-CN-ET Sterile STar Insertion Tube Extractors 5/pack YES
70-IT-3007 Box 5 Single Insertion Tubes YES
70-IT-7107 Array Insertion Elect/Tube YES
70-IT-7147LI Array Lead Insert Tubesw/Stylt YES
70-IT-7207 STar Frame EC Adapter Insertion Tube Set, Sterile YES
70-IT-AR5P Sterile STar Array Electrode Insertion Tubes Platform YES
70-IT-ARP Sterile STar Array Electrode YES
70-ST-TS1P STar Frame EC Adapter Track Stylet Set, Sterile YES
70-ZD-IKS STar Inserter Kit YES
MER-5000T Box of 5mT Tungs. Electr.ARDB1 YES
MTBPBP(DT1) miT Backloaded Electrode Pt/Ir YES
MTBWAP(JJ2) microTargeting Electrode YES
MTBWLP(ZK1) microTargeting Electrode YES
MTDPBP(AO)(AO1) mT Electrode, Sterile 5 Pack Pt/Ir Differential, 1 Meg YES
MTDPBP(AO)(AO9) mT Electrode, Sterile 5-pack YES
MTDPBP(LS)(LS3) microTargeting Sterile Elect Differential, 1 Meg, 5 Pk YES
MTDPBP(NS)(SL2) mT Electrode, Sterile 5-pack YES
MTDPBP(PS)(PS1) Platinum 1 Meg uE YES
MTDPLP(EP)(BP7) Sterile DZap Platinum L Differential YES
MTDPLP(EP)(BP8) Sterile DZap Platinum L Differential YES
MTDPLP(NS)(SL2) mT Electrode, Sterile 5-pack YES
MTDPLP(PA)(AR2) microTargeting Sterile Microelectrode 5pk Dzap L YES
MTDPLP(PA)(DB2) Sterile DZap Platinum L YES
MTDPLP(PA)(GH1) PA mT electrode Pt/Ir Dzap L YES
MTDPLP(PA)(MP1) Nexframe / DZap Leadpoint / Array Sterile/ 5pk YES
MTDPLT(EP)(BP7) Sterile DZap Platinum L Differential YES
MTDPLT(PA)(DB2) Sterile DZap Platinum L YES
MTDPXP(AO)(AO9) mT Electrode, Sterile 5-pack YES
MTDPXP(BP)(BP7) Platinum uE Differential, YES
MTDPZP(AO)(AO1) mT Electrode, Sterile 5 Pack Pt/Ir Differential, 1 Meg DZAP YES
MTDPZP(EP)(BP7) Sterile DZap Platinum Differential YES
MTDPZP(EP)(BP8) Sterile DZap Platinum Differential YES
MTDPZP(NS)(SL2) mT Electrode, Sterile 5-pack YES
MTDPZP(PA)(DB2) Sterile DZap Platinum YES
MTDPZP(PA)(GH1) PA mT electrode Pt/Ir Dzap Z YES
MTDPZP(PA)(MP1) Nexframe / DZap / Array Sterile/ 5pk YES
MTDPZT(EP)(BP7) Sterile DZap Platinum Differential YES
MTDPZT(PA)(DB2) Sterile DZap Platinum YES
MTDWBP(AO)(A10) Shielded Tungsten  1 Meg uE YES
MTDWBP(AO)(AO1) mT Electrode, Sterile 5-pack YES
MTDWBP(AO)(AO2) NonShielded Tungsten, 1 meg uE YES
MTDWBP(AO)(AO3) NonShielded Tungsten, 1 meg YES
MTDWBP(AR)(MP1) mT Platform Tungsten 1 Meg uE, YES
MTDWBP(BP)(B10) microTargeting Sterile YES
MTDWBP(BP)(BP6) microTargeting Sterile differential Microelectrode YES
MTDWBP(LS)(LS3) microTargeting Sterile Elect Differential, 1 Meg, 5 Pk YES
MTDWBP(SB)(SB2) microTargeting Sterile differential Microelectrode YES
MTDWBP(SP)(MP3) microTargeting Sterile Microelectrode 5 pk 1 Meg YES
MTDWLP(AO)(A10) Shielded Tungsten  DZap L YES
MTDWLP(AO)(PT1) Shielded Tungsten DZap L YES
MTDWLP(BP)(B10) microTargeting Sterile Microelectrode 5pk Dzap L YES
MTDWLP(BP)(BP6) Sterile DZap Tungsten L impedance YES
MTDWLP(BP)(BP8) Sterile DZap Tungsten L Impedance 5pk YES
MTDWLP(BS)(FM2) Sterile DZap Tungsten L Impedance YES
MTDWLP(SP)(AR1) Sterile DZap Tungsten Short Profile YES
MTDWLP(SP)(MP3) microTargeting Sterile Microelectrode 5 pk Dzap L YES
MTDWLP(SP)(MP4) Sterile DZap (L)Tungsten Short Profile YES
MTDWLP(SS)(BP8) Sterile DZap Tungsten Short Profile 5pk YES
MTDWLT(AR)(AR2) Sterile DZap Tungsten L YES
MTDWLT(AR)(MP1) Sterile DZap Tungsten YES
MTDWLT(BP)(BP7) Sterile Dzap Tungsten L YES
MTDWZP(AO)(A10) Shielded Tungsten  DZap Z YES
MTDWZP(AO)(AO2) NonShielded Tungsten, D.Zap YES
MTDWZP(AO)(AO3) NonShielded Tungsten, D.ZAP YES
MTDWZP(AO)(AO9) mT Electrode, Sterile 5-pack YES
MTDWZP(AO)(PT1) Shielded Tungsten DZap Z YES
MTDWZP(AR)(DB1) Sterile DZap Tungsten Differential YES
MTDWZP(AR)(MP3) Sterile DZap Tungsten Differential YES
MTDWZP(BP)(B10) microTargeting Sterile Microelectrode 5pk Dzap Z YES
MTDWZP(BP)(BP5) microTargeting Sterile differential Microelectrode YES
MTDWZP(BP)(BP8) microTargeting Sterile D.Zap YES
MTDWZP(NS)(SK2) mT Electrode, Sterile 5-pack YES
MTDWZP(NS)(SL1) mT Electrode, Sterile 5-pack YES
MTDWZP(NS)(SL2) mT Electrode, Sterile 5-pack YES
MTDWZP(SB)(NS1) mT Electrode, Sterile 5-pack YES
MTDWZP(SP)(AR1) Sterile DZap Tungsten Short Profile YES
MTDWZP(SP)(AR5) Sterile DZap Tungsten Short Profile YES
MTDWZP(SP)(MP3) microTargeting Sterile Microelectrode 5 pk Dzap Z YES
MTDWZP(SP)(MP4) Sterile DZap Tungsten Short Profile YES
MTDWZP(SS)(BP8) Sterile DZap Tungsten Short Profile 5pk YES
MTDWZT(AR)(AR2) Sterile DZap Tungsten YES
MTDWZT(AR)(MP1) Sterile DZap Tungsten YES
MTDWZT(BP)(BP7) Sterile DZap Tungsten YES
MTSWBP(JN)(JN2) Shielded mT Electrode YES
MTSWLP(JN)(JN1) mT Electrode Dzap L YES
MTTWLP(ZK2) Side by Side Microelectrode, Sterile YES

California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm.

Ethelene Oxide is on the list of chemicals in Prop. 65.

The products included in this list are sterilized using EO and have residual levels of EO that are higher than what is allowed per PROP 65, therefore the following warning is required:

⚠ WARNING: This product can expose you to chemicals including Ethylene Oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm.  For more information, go to www.P65Warnings.ca.gov.

 

The following products are manufactured by FHC and distributed by Medtronic:

MDT Part ID Description Sterile
FC1004 Sterile Drape Sleeves (PK/20) YES
FC1018 Array Elec. Insertion Tube w stylet Sterile Medtronic YES
FC1019 Lead Insertion Tube w/ Stylet, Sterile YES
FC1020 mT Microelectrode Cable YES
FC1036 Single Insertion Tube set 5x YES
FC2001 Sterile DZAP Array Insertion Electrode 5pk YES
FC2002 Sterile DZAP Single Insertion Electrode 5pk YES
FC2003 Sterile DZAP Single & Array Insertion Electrode 5pk YES
FC2004 Sterile DZAP Single & Array Insertion Electrode 5pk YES
FC4000 Box of 5 IT/electrodes kits YES
FC4001 DZAP Electrode Kit 5x Nexframe/Nexdrive/Leadpoint YES
FC5000 Box of 5 Pt Nexframe electrode YES
FC7100 Array Insertion Electrode/Tube w/ Stylet Kit YES
FC7140LI Array Lead Insert Tubes w/Stylet YES
FC8009 STar Array Electrode Insertion Tube with Stylet 5x YES
FC8011 STar Array Electrode Insertion Tube Extractor 5x YES
FC9001 STar Array Electrode Insertion Tube w/ Stylet 5x YES
FC9002 Lead Insertion Tube with Stylet 5x YES
FC9003 STar Single Electrode Insertion Tube Set 5x YES
22670 Sterile Array Microelectrode, 5 pk YES
34680 Sterile Single Microelectrode, 5pk YES
KTF1001 Sterile DZAP Single, Convenience Kit YES
KTF1002 Sterile DZAP STar Array, Convenience Kit YES