Duns Number:305524696
Device Description: Biatain® Ag Adhesive. Adhesive foam dressing with silver – antimicrobial effect for wounds 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.
Catalog Number
39632
Brand Name
Biatain
Version/Model Number
39632
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100218,K100218,K100218
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
489c6719-52da-4611-ab6e-7f282a44d60e
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
Package DI Number
05708932100854
Quantity per Package
120
Contains DI Package
05708932100847
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |