Identity
- Trade Name
- Sunoptic Technologies FDA UDI
- Generic Name
- Head-worn fibreoptic light FDA UDI
- Device Name
- headlights FDA UDI
- Model / Reference
- Headlights FDA UDI
- Description
- headlights FDA UDI
Identifiers
- Primary DI / UDI-DI
- M678HL0 FDA UDI
- FDA Product Code
- FCT FDA UDIEBA FDA UDI
- GMDN Term
- Head-worn fibreoptic light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4335 FDA UDI872.4630 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Head-worn fibreoptic light
Sunoptic Technologies by Sunoptic Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Head-worn fibreoptic light.
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- 90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
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- Surgical Headlight — GULF FIBEROPTICS, INC. · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
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 68c76eab-1389-469d-b03e-82173b1284a2 34 fields · synced May 29, 2026