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 12.5 cm, Dressing Length 5 in, Dressing Width 12.5 cm, Dressing Width 5 in.
Catalog Number
39023
Brand Name
Biatain Silicone Non-Border
Version/Model Number
39023
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
ece0f3c7-7e0c-436f-af3c-3cf3cba67b16
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
Package DI Number
05701780174633
Quantity per Package
12
Contains DI Package
05701780174541
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 |