Identity
- Trade Name
- Pioneer - Fiber Optic Cable - Bifurcated FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- 008659 FDA UDI
Identifiers
- Catalog Number
- 38-Lightcable-2 FDA UDI
- Primary DI / UDI-DI
- 00812432020699 FDA UDI
- FDA Product Code
- FDG FDA UDI
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Pioneer - Fiber Optic Cable - Bifurcated by Lumitex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Lumitex, Inc.
Sources (1)
- FDA UDI 32c25d9e-acca-4e5a-be15-85e4c236cb2c 34 fields · synced May 30, 2026