Identity
- Trade Name
- Abena FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Alginates absorb wound exudate and form a gel-like covering over the wound, helping to maintain a moist wound healing environment, promote the healing process, and minimize bleeding. FDA UDI
- Model / Reference
- 1977 FDA UDI
- Description
- Alginates absorb wound exudate and form a gel-like covering over the wound, helping to maintain a moist wound healing environment, promote the healing process, and minimize bleeding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190509001452 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
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
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Abena by Abena North America, Inc. — 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
- Abena North America, Inc.
Sources (1)
- FDA UDI a66bbb6e-bfab-4c05-b55c-d9d616d385a4 34 fields · synced May 30, 2026