Identity
- Trade Name
- General Instrument FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- Light Cable Adapter, SIGMA TLIF FDA UDI
- Model / Reference
- CI-10989 FDA UDI
- Description
- Light Cable Adapter, SIGMA TLIF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840180509708 FDA UDI
- FDA Product Code
- FTA FDA UDI
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Light source adaptor
General Instrument by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Light source adaptor.
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- Innomed, Inc. — Innomed, Inc. · Class II
- Aspen® Rigid Light Handle Adapter — Aspen Surgical Products, Inc. · Class II
- SPOTLIGHT — Depuy Spine, Inc. · Class I
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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 29565e1a-ef11-4a0b-b729-a49e5193c86c 34 fields · synced Jun 8, 2026