Identity
- Trade Name
- 90 Deg Fiber Optic HL FDA UDI
- Generic Name
- Head-worn fibreoptic light FDA UDI
- Device Name
- 90 Deg Fiber Optic HL, Universal Cable, Ratchet Headgear FDA UDI
- Model / Reference
- 04-090VUR FDA UDI
- Description
- 90 Deg Fiber Optic HL, Universal Cable, Ratchet Headgear FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816835024094 FDA UDI
- 510(k) Number
- K991572 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Head-worn fibreoptic light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Head-worn fibreoptic light
90 Deg Fiber Optic HL by Medical Illumination International, Inc — 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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Cleared under the same submission
K991572 also covers:
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc
- 90 Deg Fiber Optic HL — Medical Illumination International, 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
- Medical Illumination International, Inc
Sources (1)
- FDA UDI a6bd30f0-4f73-433d-b4b4-b4150cab3923 34 fields · synced May 30, 2026