Identity
- Trade Name
- Sunoptic Technologies FDA UDI
- Generic Name
- Hand-held examination/treatment light FDA UDI
- Device Name
- LED Rover Disoposable Series FDA UDI
- Model / Reference
- Rover Lightsource series FDA UDI
- Description
- LED Rover Disoposable Series FDA UDI
Identifiers
- Primary DI / UDI-DI
- M678DLS0 FDA UDI
- FDA Product Code
- FCW FDA UDI
- GMDN Term
- Hand-held examination/treatment light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sunoptic Technologies by Sunoptic Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sunoptic Technologies
Sources (1)
- FDA UDI 0a1daf3f-5011-4b74-9e5b-89532aecc3c2 36 fields · synced Jun 7, 2026