Identity
- Trade Name
- ExtriCARE FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Extricare Small Foam Dressing FDA UDI
- Model / Reference
- ST396-0001 FDA UDI
- Description
- Extricare Small Foam Dressing FDA UDI
Identifiers
- Catalog Number
- EC-FOAM-S-E FDA UDI
- Primary DI / UDI-DI
- 04897089070149 FDA UDI
- 510(k) Number
- K140634 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
ExtriCARE by Alleva Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Alleva Medical, Ltd.
Sources (1)
- FDA UDI 6fe0af51-0330-4c88-8a2e-6fa02c19de98 35 fields · synced Jun 8, 2026