AQUACEL AG

Basic Information

• Brand Name: AQUACEL AG
• Primary DI: 00768455124305
• Version / Model: 412009
• Catalog Number: 412009
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 8
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: f04e853a-1fe1-4c4b-b863-d64c04d0c290
• Distribution End Date: 2022-05-20

Device Description

AQUACEL AG SCD DRS 9X10CM (1X10PK) US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00768455124305	GS1
Package	00768455111169	GS1	Carton	10	Not in Commercial Distribution	2022-05-20
Package	10768455111166	GS1	Case	20	Not in Commercial Distribution	2022-05-20

Premarket Submissions

Submission Number	Supplement Number
K091034	000

Device Sizes

Type	Value	Unit	Text
Width	10	Centimeter
Length	9	Centimeter