FDA.reportPublic FDA data

STar™ Drive Electrode Carrier

Primary DI
00873263008348
Brand
STar™ Drive Electrode Carrier
Company
FHC, INC.
Model
FC8010-00834
Catalog number
FC8010
Device description
STar™ Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive
Published
2021-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092562000MICROTARGETING STAR DRIVE SYSTEM, COMPONENTSFHC, Inc.2009-09-18HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10873263008345PrimaryGS10
00873263008348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087326300834510873263008345
00873263008348008732630083488732630083480873263008348

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical micro targeting driveA calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature057 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags#

DUNS number
108179458
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00873263003039WayPoint™ Indexing Ring66-MP-IR-0030366-MP-IR2016-09-17
00873263008522microTargeting™ PlatformMP-KIT-A-ST-00852MP-KIT-A-ST2023-07-26
00873263007693microTargeting™ Insertion Tube66-IT-IT2P-0076966-IT-IT2P2026-05-08
00873263007785microTargeting™ Insertion Tube66-IT(IT2)-0077866-IT(IT2)2026-05-08
00873263007792microTargeting™ Insertion Tube66-PT(IT2)-0077966-PT(IT2)2026-05-08
00873263003046WayPoint™ Surgical Kit66-WP-SKS-0030466-WP-SKS2016-09-17
00873263003190WayPoint™ Implant Kit66-WP-IKS-0031966-WP-IKS2016-09-17
00873263009604microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
00873263009468microTargeting™ PlatformMP-KIT-P-VO-00946MP-KIT-P-VO2026-03-16
00873263009475microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
10873263009625microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009611microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263002254STar™ Drive XL Frame Adapter70-FA-RD-XL-0022570-FA-RD-XL2016-09-17
00873263002285STar™ Drive XL Frame Adapter70-FA-LX-XL-0022870-FA-LX-XL2016-09-17
00873263002322STar™ Drive Frame Adapter70-FA-LX-0023270-FA-LX2016-09-17
00873263002360microTargeting™ STar™ Array Insertion Tube Extractor70-CN-ET-0023670-CN-ET2016-09-17
00873263006047WayPoint™ Entry Offset Mounting Hub66-MP-EH-0060466-MP-EH2018-04-01
00873263006184STar™ Drive Frame Adapter70-FA-GP-0061870-FA-GP2017-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
04719878692021Surgical Equipment DrapeBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_5.3mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20