Identity
- Trade Name
- Extremity Care FDA UDI
- Generic Name
- Tissue injection cannula FDA UDI
- Device Name
- Cannula Kit Standard w/Scalpel Kit includes: Primary DI: 00850003042268 Version: ALC125 Device Description: Straight Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Straight Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11) FDA UDI
- Model / Reference
- ALC100S FDA UDI
- Description
- Cannula Kit Standard w/Scalpel Kit includes: Primary DI: 00850003042268 Version: ALC125 Device Description: Straight Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Straight 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
- 00850003042237 FDA UDI
- FDA Product Code
- GEA FDA UDIGES FDA UDI
- GMDN Term
- Tissue injection cannula 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 f84862a4-74e9-4e9d-8a13-f95f9723a3c3 35 fields · synced Jun 8, 2026