Duns Number:078740398
Device Description: Foam Dressing with Film Backing and Adhesive Border.
Catalog Number
-
Brand Name
Abena
Version/Model Number
1965
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2023
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
d85cb34f-9b7f-4e88-8372-058685bc343c
Public Version Date
January 03, 2022
Public Version Number
4
DI Record Publish Date
May 29, 2020
Package DI Number
00190509001100
Quantity per Package
10
Contains DI Package
00190509001353
Package Discontinue Date
January 01, 2022
Package Status
Not in Commercial Distribution
Package Type
Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 127 |