Identity
- Trade Name
- AQUACEL AG FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI FDA UDI
- Model / Reference
- 420670 FDA UDI
- Description
- AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI FDA UDI
Identifiers
- Catalog Number
- 420670 FDA UDI
- Primary DI / UDI-DI
- 00768455125104 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 — 30 Centimeter FDA UDILength — 9 Centimeter FDA UDI
AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI is a wound covering dressing designed to absorb exudate in wounds, promoting wound healing while reducing microbial colonization. It features an antimicrobial agent and a hydrophilic-gel composition, making it suitable for various types of wounds. Made from a range of materials including chitosan and alginate, this device is available for single-use applications.
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 8bbf1169-debc-4e5f-a73d-44b929e7f8fb 37 fields · synced Jun 20, 2026