Duns Number:216344051
Device Description: Non-woven adhesive wound dressing
Catalog Number
66000320
Brand Name
PRIMAPORE ADHESIVE DRESSING 25*10CM
Version/Model Number
66000320
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
87906efa-2a9c-44e1-afe9-dfaffc29fca3
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
July 08, 2020
Package DI Number
05000223420321
Quantity per Package
20
Contains DI Package
05000223420314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |