Identity
- Trade Name
- Single use Surgical Optical Fiber FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, single-use FDA UDI
- Device Name
- Single use Surgical Optical Fiber Ø 800 µm FDA UDI
- Model / Reference
- OAF088001 FDA UDI
- Description
- Single use Surgical Optical Fiber Ø 800 µm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033945934408 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single use Surgical Optical Fiber by Quanta System Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA UDI bbfdbbe2-497b-4841-9e3b-300d25781543 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026