Duns Number:724981491
Device Description: Non-Woven Island Dressing (Sterile)
Catalog Number
-
Brand Name
NA
Version/Model Number
Sterile
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"
-
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
a50f29b8-e7af-4356-a750-6cc85a61c66e
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 2022
Package DI Number
16974795050193
Quantity per Package
40
Contains DI Package
06974795050196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |