DEVICE: Advazorb Silfix (05060031475104)
Device Identifier (DI) Information
Advazorb Silfix
CR4180
In Commercial Distribution
BRIGHTWAKE LIMITED
CR4180
In Commercial Distribution
BRIGHTWAKE LIMITED
Hydrophilic foam dressing with soft silicone wound contact layer, 15cm x 15cm. Advazorb Silfix 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial |
A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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NAC | Dressing, Wound, Hydrophilic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 15 Centimeter |
Width: 15 Centimeter |
Device Record Status
58df3daa-cafa-445c-8788-52406638142a
August 04, 2023
1
July 27, 2023
August 04, 2023
1
July 27, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05060031475111 | 10 | 05060031475104 | In Commercial Distribution | Retail | |
05060031475128 | 10 | 05060031475111 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441623751500
info@advancis.co.uk
info@advancis.co.uk