Identity
- Trade Name
- microTargeting™ STar™ Insertion Tube FDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID FDA UDI
- Model / Reference
- FC8009-00119 FDA UDI
- Description
- microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID FDA UDI
Identifiers
- Catalog Number
- FC8009 FDA UDI
- Primary DI / UDI-DI
- 10873263001193 FDA UDI
- 510(k) Number
- K092562 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Intracerebral cannula, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
MR Unsafe FDA UDI
microTargeting™ STar™ Insertion Tube by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092562 also covers:
- Cable Management System — FHC, INC.
- Lower Lead Depth Stop — FHC, INC.
- STar™ Drive Accesories Kit — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 9f58dfb8-8043-4ba1-aee6-01f43a516216 38 fields · synced Jun 1, 2026