Identity
- Trade Name
- Fiber Optic Light Cable FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g. and endoscope or a headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fiber optic bundle. This is a reusable device. FDA UDI
- Model / Reference
- 2.8mm bundle diameter, 8' length, mono cable FDA UDI
- Description
- A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g. and endoscope or a headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fiber optic bundle. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857580006584 FDA UDI
- 510(k) Number
- K021931 FDA UDI
- FDA Product Code
- FFS FDA UDIHBI FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4580 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
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
No
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: Fibreoptic light cable
Fiber Optic Light Cable by Gulf Fiberoptics, Inc. — Class II — 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
Cleared under the same submission
K021931 also covers:
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, 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
- Gulf Fiberoptics, Inc.
Sources (1)
- FDA UDI 41e0cc24-6a08-4d04-b579-54aa1c05a9d3 35 fields · synced May 30, 2026