Biatain 39632

GUDID 05708932100854

Biatain® Ag Adhesive. Adhesive foam dressing with silver – antimicrobial effect for wounds with extra fragile skin. Thickness 3 mm, Dressing Length 5 in, Dressing Width 5 in.

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 05708932100854
• NIH Device Record Key: 489c6719-52da-4611-ab6e-7f282a44d60e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biatain
• Version Model Number: 39632
• Catalog Number: 39632
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Device Size Text, specify: 0
• Width: 5 Inch
• Length: 5 Inch
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932100830 [Primary]
GS1	05708932100847 [Package]; Contains: 05708932100830; Package: Retail Box [5 Units]; In Commercial Distribution
GS1	05708932100854 [Package]; Contains: 05708932100847; Package: Shipper Box [120 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-19
• Device Publish Date: 2021-04-09

Devices Manufactured by Coloplast A/S

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• 03600040953716 - Coloplast: 2024-04-22
• 03600040953747 - Coloplast: 2024-04-22
• 03600040963845 - Coloplast: 2024-04-22
• 03600040963913 - Coloplast: 2024-04-22
• 03600040963999 - Coloplast: 2024-04-22
• 03600040964057 - Coloplast: 2024-04-22
• 03600040964156 - Coloplast: 2024-04-22