Duns Number:006961700
Device Description: Athletic Tape - 2ct (10yds per Roll) - Up&Up
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245-07-0658
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
d8c5a1a0-d371-4134-8355-66892bf09452
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 26, 2021
Package DI Number
10014007422229
Quantity per Package
24
Contains DI Package
00014007422222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |