CovaWound Alginate Ag 10x10cm

Basic Information

• Brand Name: CovaWound Alginate Ag 10x10cm
• Primary DI: 00825439012161
• Version / Model: 3101010
• Company Name: Covalon Technologies Ltd
• Labeler DUNS: 206936101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: 01ed191c-bf18-41f3-b4f3-421de552f8c3

Device Description

Alginate dressing with silver

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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
Package	00825439012178	GS1	Carton	10	In Commercial Distribution
Primary	00825439012161	GS1
Package	10825439012236	GS1	Shipper	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K071442	000

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Width	10	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius