Duns Number:305524696
Device Description: Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general pu Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general purposes. Klinikpackung. Dressing Length 7.5 cm, Dressing Length 3 in, Dressing Width 7.5 cm, Dressing Width 3 in.
Catalog Number
39021
Brand Name
Biatain Silicone Non-Border
Version/Model Number
39021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
17f98e42-8ac5-427a-9fe6-058010b79f0c
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
Package DI Number
05701780174510
Quantity per Package
10
Contains DI Package
05701780210645
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail 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 |