Identity
- Trade Name
- AQUACEL AG FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- AQUACEL AG SCD DRS 9X10CM (1X10PK) US FDA UDI
- Model / Reference
- 412009 FDA UDI
- Description
- AQUACEL AG SCD DRS 9X10CM (1X10PK) US FDA UDI
Identifiers
- Catalog Number
- 412009 FDA UDI
- Primary DI / UDI-DI
- 00768455124305 FDA UDI
- 510(k) Number
- K091034 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Classification
- Device Class
- U 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Centimeter FDA UDILength — 9 Centimeter FDA UDI
Aquacel Ag by Convatec, Purchasing Department — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI f04e853a-1fe1-4c4b-b863-d64c04d0c290 37 fields · synced May 30, 2026