Duns Number:007138183
Device Description: Cramer Pro-Lastic Tear Stretch Tape, 1 case 16 rolls of 3" x 7.5 yard black cotton stretc Cramer Pro-Lastic Tear Stretch Tape, 1 case 16 rolls of 3" x 7.5 yard black cotton stretch tape, Tape and Bandage, Adhesive
Catalog Number
-
Brand Name
Cramer Pro-Lastic Tear Stretch Tape
Version/Model Number
283008
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
c09b0142-0093-4ba6-b030-44a09548ff3a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 27, 2018
Package DI Number
10311960751787
Quantity per Package
6
Contains DI Package
00311960751780
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 |