Duns Number:004163390
Device Description: TheraBand Kinesiology Tape Precut Roll- Beige/ Beige, TheraBand Kinesiology Tape Precut Ro TheraBand Kinesiology Tape Precut Roll- Beige/ Beige, TheraBand Kinesiology Tape Precut Roll- Black/ Gray, Hot/Cold Compress, gel and Spray
Catalog Number
-
Brand Name
Performance Health Counter Top Display
Version/Model Number
13506
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2019
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
Yes
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
6e2fe20f-7fd9-497b-a547-dcced488a1fd
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |