Identity
- Trade Name
- BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 FDA UDI
- Model / Reference
- 040-751U FDA UDI
- Description
- BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788722625 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Laryngoscope blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BriteBlade Pro Evo Single-Use Fiber Optic Mac 1 by Flexicare Medical Limited — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (1)
- FDA UDI 63744744-863c-4891-9bb5-da5005d4c622 34 fields · synced Jun 1, 2026