Advazorb Silfix

Basic Information

• Brand Name: Advazorb Silfix
• Primary DI: 05060031475180
• Version / Model: CR4182
• Company Name: BRIGHTWAKE LIMITED
• Labeler DUNS: 226502201
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-27
• Public Version: 1
• Public Version Date: 2023-08-04
• Public Version Status: New
• Public Device Record Key: 6cff9fc8-ae46-42c1-86be-3ef89b5aa059

Device Description

Hydrophilic foam dressing with soft silicone wound contact layer, 20cm x 20cm. 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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060031475197	GS1	Retail	10	In Commercial Distribution
Primary	05060031475180	GS1
Package	05060031475203	GS1	Shipper	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	20	Centimeter
Width	20	Centimeter