Identity
- Trade Name
- STar™ Drive Insertion Tube Extractor FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, single-use FDA UDI
- Device Name
- STar(TM) Drive Array Electrode Insertion Tube Extractor, 5x, Sterile, for use with STar(TM) Array Insertion Tubes FDA UDI
- Model / Reference
- FC8011-00902 FDA UDI
- Description
- STar(TM) Drive Array Electrode Insertion Tube Extractor, 5x, Sterile, for use with STar(TM) Array Insertion Tubes FDA UDI
Identifiers
- Catalog Number
- FC8011 FDA UDI
- Primary DI / UDI-DI
- 10873263009021 FDA UDI
- 510(k) Number
- K011775 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Intracerebral cannula, nonimplantable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Intracerebral cannula, nonimplantable, single-use
STar™ Drive Insertion Tube Extractor by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral cannula, nonimplantable, single-use.
- Smartflow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class II
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- Cannula Needle Set — KATALYST SURGICAL, LLC · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
- SmartFlow — Clearpoint Neuro, Inc. · Class I
Cleared under the same submission
K011775 also covers:
- 33 cm Lead Insertion Tube Set — FHC, INC.
- Microtargeting ™ STar Drive Adapter — FHC, INC.
- microTargeting Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
- microTargeting™ Electrode and Insertion Tube — FHC, INC.
- microTargeting™ Frame Adapter — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI df15de96-2144-4d4d-bd94-6018c8fcd782 37 fields · synced May 30, 2026