Identity
- Trade Name
- Lumitex 3.5mm Fiber Optic Cable FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Model / Reference
- 012004 FDA UDI
Identifiers
- Catalog Number
- 012682 FDA UDI
- Primary DI / UDI-DI
- 00812432021696 FDA UDI
- FDA Product Code
- FDG FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4530 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
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
Category: Fibreoptic light cable
Lumitex 3.5mm Fiber Optic Cable by Lumitex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
- JEDMED — JEDMED Instrument Company · Class I
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Gimmi — Gimmi GmbH · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- FENTEX — FENTEX medical GmbH · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (1)
- FDA UDI de9efe27-9ce4-4cb3-a5cf-926baed87aad 33 fields · synced Jun 1, 2026