Identity
- Trade Name
- Advazorb Silfix Lite FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Hydrophilic foam dressing with soft silicone wound contact layer, 7.5cm x 7.5cm. Advazorb Silfix Lite is a self adherent absorbent dressing with a Silfix® soft silicone wound contact layer. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound and provides gentle release. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The backing is breathable, prevents strike through and protects the wound. FDA UDI
- Model / Reference
- CR4185 FDA UDI
- Description
- Hydrophilic foam dressing with soft silicone wound contact layer, 7.5cm x 7.5cm. Advazorb Silfix Lite is a self adherent absorbent dressing with a Silfix® soft silicone wound contact layer. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound and provides gentle release. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The backing is breathable, prevents strike through and protects the wound. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031475302 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
- Length — 7.5 Centimeter FDA UDIWidth — 7.5 Centimeter FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Advazorb Silfix 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 4adfd605-57ae-44f4-8f41-b5b7ddeea7ac 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026