Identity
- Trade Name
- Extremity Care FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- Cannula Kit Cobra w/Scalpel Kit Includes: Primary DI: 00850003042282 Version: ALC325 Device Description: Cobra Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11) FDA UDI
- Model / Reference
- ALC300S FDA UDI
- Description
- Cannula Kit Cobra w/Scalpel Kit Includes: Primary DI: 00850003042282 Version: ALC325 Device Description: Cobra Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003042251 FDA UDI
- FDA Product Code
- GES FDA UDIGEA FDA UDI
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Category: Manual scalpel blade, single-useTissue injection cannula
Extremity Care by Extremity Care, Llc — 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
- Extremity Care, Llc
Sources (1)
- FDA UDI db5e64d4-e213-4d38-b17f-593d8baae712 34 fields · synced May 30, 2026