Duns Number:047025993
Device Description: Kinesiology Tape Pre Cut (2"x16.4")
Catalog Number
-
Brand Name
Vive
Version/Model Number
RHB2078BLK2W16L
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
-
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
34e9d101-80e2-4173-a345-5ca4e60473b6
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 26, 2022
Package DI Number
10850041211562
Quantity per Package
100
Contains DI Package
00850041211565
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |