Identity
- Trade Name
- Altair HI 2 FDA UDI
- Generic Name
- Head-worn fibreoptic light FDA UDI
- Device Name
- Fiber Optic Headlight FDA UDI
- Model / Reference
- QED-7800 FDA UDI
- Description
- Fiber Optic Headlight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013851521 FDA UDI
- FDA Product Code
- FCT FDA UDI
- GMDN Term
- Head-worn fibreoptic light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4335 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Head-worn fibreoptic light
Altair HI 2 by Qed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Head-worn fibreoptic light.
- Sunoptic Technologies — Sunoptic Technologies · Class II
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- Surgical Headlight — GULF FIBEROPTICS, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qed, Inc.
Sources (1)
- FDA UDI 57d2ba88-50f5-4b75-bfaa-0d95ff4c27e3 34 fields · synced Jun 8, 2026