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microTargeting™ STar™ Insertion Tube Set
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ STar™ Insertion Tube Set FDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(AR22): Insertion Tube - 126mm tube length, 1.83mm od, .97mm id. (does not enter brain) IT(AR23): Insertion Tube with stylet - 208mm tube length, .60mm id FDA UDI
- Model / Reference
- 70-IT-7107-00233 FDA UDI
- Description
- microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(AR22): Insertion Tube - 126mm tube length, 1.83mm od, .97mm id. (does not enter brain) IT(AR23): Insertion Tube with stylet - 208mm tube length, .60mm id FDA UDI
Identifiers
- Catalog Number
- 70-IT-7107 FDA UDI
- Primary DI / UDI-DI
- 00873263002339 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
- 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
Category: Intracerebral cannula, implantable
microTargeting™ STar™ Insertion Tube Set by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral cannula, implantable.
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
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 4a09ff7c-fc1b-4386-b753-f9eebd92e3a0 37 fields · synced May 30, 2026