Duns Number:006961700
Device Description: Plastic Strips Bandages, 3/4 IN x 3 IN (1.9 cm x 7.6 cm)
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245077813
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"
Yes
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
6527eb40-e13b-409b-bddd-9e77e75b2c77
Public Version Date
February 22, 2022
Public Version Number
1
DI Record Publish Date
February 14, 2022
Package DI Number
10017276238652
Quantity per Package
72
Contains DI Package
00017276238655
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |