Duns Number:216344051
Device Description: Non-woven adhesive wound dressing
Catalog Number
66000318
Brand Name
PRIMAPORE ADHESIVE DRESSING 15*8CM
Version/Model Number
66000318
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
b9accd6c-894c-4606-9a20-130624c1f8bb
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
July 08, 2020
Package DI Number
05000223420260
Quantity per Package
20
Contains DI Package
05000223420253
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 |