Duns Number:007138183
Device Description: Cramer Blister Foam, 25 Pack Box, Tape and Bandage, Adhesive
Catalog Number
-
Brand Name
Cramer Blister Foam
Version/Model Number
030907
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)
Yes
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
2165b2a6-8751-4795-bcc9-e4329c15e214
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 01, 2018
Package DI Number
10311960708309
Quantity per Package
102
Contains DI Package
00311960708302
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |