Identity
- Trade Name
- Sunoptic Technologies FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Fiberoptic Cables for headlight FDA UDI
- Model / Reference
- Headlight Cables FDA UDI
- Description
- Fiberoptic Cables for headlight FDA UDI
Identifiers
- Primary DI / UDI-DI
- M678HLC0 FDA UDI
- 510(k) Number
- K901035 FDA UDI
- FDA Product Code
- FST FDA UDIEQH FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI874.4350 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fibreoptic light cable
Sunoptic Technologies by Sunoptic Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fibreoptic light cable.
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- JEDMED — JEDMED Instrument Company · Class I
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Cleared under the same submission
K901035 also covers:
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- Arthrex® — Arthrex, Inc.
- CONMED — Conmed Corporation
- PIPELINE — Depuy Spine, Inc.
- PIPELINE — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- Snowden-Pencer — STERIS CORPORATION
- Snowden-Pencer — STERIS CORPORATION
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
- Sunoptic Technologies
Sources (1)
- FDA UDI f173818b-47d5-40fe-8491-243a29384367 35 fields · synced May 29, 2026