FDA.reportPublic FDA data

microTargeting™ STar™ Drive Insertion Tube Set

Primary DI
00873263002179
Brand
microTargeting™ STar™ Drive Insertion Tube Set
Company
FHC, INC.
Model
70-IT-AR-00217
Catalog number
70-IT-AR
Device description
STar(TM) Drive Array Electrode Insertion Tube Set for use with stereotactic frames, non-sterile Contains: 6 - IT(AR16) Guide Tube (does not enter brain) 6 - IT(AR17) Insertion Tube with Stylet - 241.5mm length, 0.90mm od, 0.60mm id 1 - IT(AR3), DBS Lead Insertion Tube with Stylet - 239.85mm length, 1.83mm od, 1.60mm id 2 - Insertion Tube Extractors
Published
2016-09-17
Public version status
Update
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
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00873263002179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263002179008732630021798732630021790873263002179

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral cannula, implantableA sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 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
1
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
false
Expiration date on label
true
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
00873263009468microTargeting™ PlatformMP-KIT-P-VO-00946MP-KIT-P-VO2026-03-16
00873263009475microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009451microTargeting™ Drill Guide66-MO-30-0095966-MO-302026-02-10
00873263009574STar™ Drive Frame Adapter70-FA-LS-0095870-FA-LS2026-01-25
00873263009314Visualase Neuro Accessories9736536-0093197365362025-12-12
00873263009321Visualase Anchor Bolt Tools9736537-0093297365372025-12-12
00873263009338Visualase MR Stiffening Stylet9736538-0093397365382025-12-12
00873263009345Visualase Anchor Bolt Driver9736539-0093497365392025-12-12
00873263009352Visualase Anchor Bolt Driver Guide9736540-0093597365402025-12-12
00873263009369Visualase Anchor Bolt Driver Guide9736541-0093697365412025-12-12
00873263009376Visualase Anchor Bolt Driver Guide9736542-0093797365422025-12-12
00873263009383Visualase Anchor Bolt Driver Guide9736543-0093897365432025-12-12
00873263009390Visualase Sterilization & Storage Tray9736544-0093997365442025-12-12
00873263009406Visualase Anchor Bolt Removal Tool9736545-0094097365452025-12-12
00873263009499microTargeting™ Electrode35325Z-0094935325Z2025-12-02
10873263000615microTargeting™ Array Electrode Carrier and ClampFC1021-00061-FC10212018-07-16
10873263009427microTargeting™ ElectrodeMTDWLP(BP)(BP16)-00942MTDWLP(BP)(BP16)2025-05-21
00873263009413microTargeting™ ElectrodeMTDWLN(BP)(BP16)-00941MTDWLN(BP)(BP16)2025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089664ELMED INCORPORATEDELMED INCORPORATEDHAO2026-03-17
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00810220800034Adler Instrument CompanyAdler, Inc.HAO2026-03-17
04058749078770NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749082357NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749123500NAFehling Instruments GmbH & Co. KGHAO2026-03-05
00816589021608Mini-Bolt Accessory KitMONTERIS MEDICAL INCHAO2026-02-23
00810123209835Adler Instrument CompanyAdler, Inc.HAO2026-02-10
04058749068443NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
00873263009345Visualase Anchor Bolt DriverFHC, INC.HAO2025-12-12
00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009369Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009376Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009390Visualase Sterilization & Storage TrayFHC, INC.HAO2025-12-12
00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
04058749001846NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749002010NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749068467NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069969NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069976NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08