Duns Number:007138183
Device Description: Cramer Moleskin 1 box of 3" x 25 yard beige
Catalog Number
-
Brand Name
Cramer Moleskin
Version/Model Number
136150
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2020
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
d6155604-3f3e-4c6f-b064-e26999453cf5
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
February 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |