Duns Number:006961700
Device Description: all-purpose, Hydrocolloid Gel Bandages, 0.78 IN x 2.36 IN (20 mm x 60 mm)
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245076422
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
35ddaa02-cb03-48c2-87f9-85588b770e7e
Public Version Date
January 27, 2022
Public Version Number
1
DI Record Publish Date
January 19, 2022
Package DI Number
10017276238669
Quantity per Package
72
Contains DI Package
00017276238662
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 |