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| 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
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 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 |
| 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 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
| 05701780278034 - Titan | 2025-08-06 |
| 03600040974919 - BoNee | 2025-05-28 |
| 03600040974858 - BoNee | 2025-05-28 |
| 05701780356084 - SenSura Mio | 2025-05-05 |
| 05701780356145 - SenSura Mio | 2025-05-05 |
| 05701780356206 - SenSura Mio | 2025-05-05 |
| 05701780356268 - SenSura Mio | 2025-05-05 |
| 05701780356329 - SenSura Mio | 2025-05-05 |
Trademark Results [Biatain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIATAIN 79010012 3071250 Live/Registered |
Coloplast A/S 2005-03-01 |
 BIATAIN 75410353 2245721 Live/Registered |
Coloplast A/S 1997-12-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.