Identity
- Trade Name
- Pharos HD CCU FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- Surgical Camera & Light FDA UDI
- Model / Reference
- P003505 FDA UDI
- Description
- Surgical Camera & Light FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851610007336 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical video camera
Pharos HD CCU by Long Island Tech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical video camera.
- Procam HD II — Ecleris · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Disposable cover_35x100_wide — GOOD DOCTORS CO., LTD. · Class I
- PROCAM PACK — Ecleris · Class I
- FireCam HD Intraoral Camera — DIGIRAY Corp. · Class I
- Procam HD CMOS II CONSOLE — Ecleris · Class I
- PROCAM Basic PAL — Ecleris · Class I
- Accu-Beam — Transamerican Technologies International · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Long Island Tech
Sources (1)
- FDA UDI 21c639c9-10f5-486d-92a5-11993c9e8e6c 34 fields · synced May 30, 2026