Advazorb Heel

Basic Information

• Brand Name: Advazorb Heel
• Primary DI: 05060031476460
• Version / Model: CR4502
• 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: e23297c1-ea85-4088-b3d6-b8c207db98e2

Device Description

Absorbent foam dressing with film backing, 17cm X 21cm. Advazorb Heel is a conformable, non-adherent, absorbent, polyurethane foam dressing with a breathable film backing designed to fit around the heel. A non-adherent foam dressing with excellent fluid handling properties. Ideal for use under compression bandaging with its fluid retention, low profile and low friction film backing. Advazorb Heel also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices.

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	05060031482171	GS1	Retail	5	In Commercial Distribution
Primary	05060031476460	GS1
Package	05060031482188	GS1	Shipper	20	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	21	Centimeter
Width	17	Centimeter