Duns Number:004163390
Device Description: Cramer AT Pro Tape, White 2" x 15 yards (24 Rolls)
Catalog Number
-
Brand Name
Cramer AT Pro Tape
Version/Model Number
280962
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"
Yes
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
0175bcc7-bef7-40c4-9cd0-3be9a46ffa36
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 01, 2019
Package DI Number
10311960003190
Quantity per Package
144
Contains DI Package
00311960003193
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 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |