Identity
- Trade Name
- Advazorb Lite FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Hydrophilic foam dressing with film backing, 10cm x 10cm. A soft, conforming non-adherent hydrophilic polyurethane foam wound dressing with pink polyurethane film backing. Advazorb Lite has high fluid absorbency and retention characteristics. FDA UDI
- Model / Reference
- CR4172 FDA UDI
- Description
- Hydrophilic foam dressing with film backing, 10cm x 10cm. A soft, conforming non-adherent hydrophilic polyurethane foam wound dressing with pink polyurethane film backing. Advazorb Lite has high fluid absorbency and retention characteristics. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031474787 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
Dimensions & Sizes
- Size
- Width — 10 Centimeter FDA UDILength — 10 Centimeter FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Advazorb Lite by Brightwake Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brightwake Limited
Sources (2)
- FDA UDI 79bd6361-391c-43ab-8e2a-fcfbc122a0f8 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026