Biatain Ag Non-Adhesive 9622

GUDID 05708932100793

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 05708932100793
• NIH Device Record Key: 455d2a74-9f3f-4435-84e4-36e96e1463de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biatain Ag Non-Adhesive
• Version Model Number: 9622
• Catalog Number: 9622
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Width: 4 Inch
• Length: 4 Inch
• Length: 10 Centimeter
• Width: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932100779 [Primary]
GS1	05708932100786 [Package]; Contains: 05708932100779; Package: Retail Box [5 Units]; In Commercial Distribution
GS1	05708932100793 [Package]; Contains: 05708932100786; Package: Shipper Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100218

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Biatain Ag Non-Adhesive]

• 05708932100823: 9625
• 05708932100793: 9622