Identity
- Trade Name
- Clarus TURBO LED Light Source FDA UDI
- Generic Name
- Intubation light source FDA UDI
- Device Name
- Clarus TURBO LED Light Source FDA UDI
- Model / Reference
- 5197-201 FDA UDI
- Description
- Clarus TURBO LED Light Source FDA UDI
Identifiers
- Catalog Number
- 5197-201 FDA UDI
- Primary DI / UDI-DI
- B06751972010 FDA UDI
- 510(k) Number
- K971455 FDA UDI
- FDA Product Code
- FTI FDA UDI
- GMDN Term
- Intubation light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Category: Intubation light source
Clarus TURBO LED Light Source by Clarus Medical, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Clarus Medical, Llc
Sources (1)
- FDA UDI 37c3af32-1232-48a2-a7a7-eeed8f89c006 37 fields · synced May 30, 2026