Identity
- Trade Name
- FLX-LITE FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- FLX-LITE, FLEXIBLE SURGICAL LITE, 127 MM (5") FDA UDI
- Model / Reference
- 3058A FDA UDI
- Description
- FLX-LITE, FLEXIBLE SURGICAL LITE, 127 MM (5") FDA UDI
Identifiers
- Catalog Number
- 3058A FDA UDI
- Primary DI / UDI-DI
- 10845854044353 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5 Inch FDA UDILength — 127 Millimeter FDA UDI
Category: Fixed examination/treatment room light
Flx-Lite by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI b89ed859-def4-424f-b224-363e28429b9d 37 fields · synced May 30, 2026