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microTargeting™ STar™ Drive Insertion Tube Set
FDA UDIClass I (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ STar™ Drive Insertion Tube Set FDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 70-IT-AR-00217 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 70-IT-AR FDA UDI
- Primary DI / UDI-DI
- 00873263002179 FDA UDI
- FDA Product Code
- HAO FDA UDIHAW FDA UDI
- GMDN Term
- Intracerebral cannula, implantable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 FDA UDI882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Intracerebral cannula, implantable
microTargeting™ STar™ Drive Insertion Tube Set by Fhc, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intracerebral cannula, implantable.
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- Cannula — Alpha Omega Engineering Corp. · Class II
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- Cannula — Alpha Omega Engineering Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 5a4b778d-d8a8-495a-8aaa-eabf4a274ab7 36 fields · synced Jun 8, 2026