Duns Number:007138183
Device Description: Cramer Taping Kit-3 rolls of poly / cotton athletic tape / 1 roll foam tape underwrap / 1 Cramer Taping Kit-3 rolls of poly / cotton athletic tape / 1 roll foam tape underwrap / 1 roll cohesive stretch tape / 1 zip cut tape cutter
Catalog Number
-
Brand Name
Cramer Sports Medicine
Version/Model Number
762829
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)
Yes
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
04a918c4-9b1a-4398-b073-438d49886db3
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 09, 2019
Package DI Number
80311960751748
Quantity per Package
8
Contains DI Package
20311960751746
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 |