Duns Number:333450844
Device Description: asia-med Kinesiology Tape - BLUE: made of cotton fabric with a medical grade acrylic adhe asia-med Kinesiology Tape - BLUE: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6) Size: length 10 m, width 5 cm Color: Blue Sales unit: 1 roll
Catalog Number
A006701
Brand Name
ASIA MED
Version/Model Number
TAPE 5X10 - BLUE
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)
-
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
3d2ad7bc-53e7-4922-a6c1-71a16b61a01c
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 31, 2018
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 | 18 |