Biatain Fiber Ag

Basic Information

• Brand Name: Biatain Fiber Ag
• Primary DI: 05708932764629
• Version / Model: 33578
• Catalog Number: 33578
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-22
• Public Version: 1
• Public Version Date: 2024-12-02
• Public Version Status: New
• Public Device Record Key: 847d4524-3de5-4fef-ac9d-ab7507efdd5b

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 Safe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
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	05708932764520	GS1	Shipper Box	22	In Commercial Distribution
Package	05708932764575	GS1	Retail Box	5	In Commercial Distribution
Primary	05708932764629	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231953	000

Device Sizes

Type	Value	Unit	Text
Width	20	Centimeter
Length	30	Centimeter
Device Size Text, specify			Dressing Shape Rectangular
Length	12	Inch
Width	8	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.