Duns Number:004163390
Device Description: Theraband Kinesiology Tape, 2”x16.4’ Continuous Roll 2 Pack, Beige/Beige
Catalog Number
-
Brand Name
TheraBand Kinesiology Tape
Version/Model Number
13999
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
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
3b60375e-09ee-419c-8d8b-d12810324fdc
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 10, 2019
Package DI Number
10087453139997
Quantity per Package
12
Contains DI Package
00087453139990
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 |