Biatain Ag Adhesive 9641

GUDID 05708932442107

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 05708932442107
• NIH Device Record Key: cf7669f1-3fff-4133-ba1f-bd61db2e31aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biatain Ag Adhesive
• Version Model Number: 9641
• Catalog Number: 9641
• 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
• 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

• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter
• Length: 9 Inch
• Device Size Text, specify: 0
• Width: 9 Inch
• Width: 23 Centimeter
• Length: 23 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932442091 [Package]; Contains: 05708932488822; Package: Retail Box [5 Units]; In Commercial Distribution
GS1	05708932442107 [Package]; Contains: 05708932442091; Package: Shipper Box [16 Units]; In Commercial Distribution
GS1	05708932488822 [Primary]

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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Biatain Ag Adhesive]

• 05708932442121: 9643
• 05708932369732: 9635
• 05708932442107: 9641