Biatain Silicone Ag Sacral 39651

GUDID 05701780210393

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 05701780210393
• NIH Device Record Key: aad1f27c-c9cb-4a83-a44b-91a74e5bade9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biatain Silicone Ag Sacral
• Version Model Number: 39651
• Catalog Number: 39651
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 25 Centimeter
• Length: 25 Centimeter
• Length: 9.8 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 9.8 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05701780210393 [Package]; Contains: 05701780211444; Package: Retail Box [5 Units]; In Commercial Distribution
GS1	05701780210409 [Package]; Package: Shipper Box [18 Units]; In Commercial Distribution
GS1	05701780211444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191536

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 Silicone Ag Sacral]

• 05701780210393: 39651
• 05701780210379: 39650