Duns Number:080935429
Device Description: Adhesive Remover,Single Use Towelette, Unscented
Catalog Number
MS71050
Brand Name
Uni-Patch
Version/Model Number
MS71050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2020
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KOX
Product Code Name
SOLVENT, ADHESIVE TAPE
Public Device Record Key
6fe000a5-8ebb-406d-b115-188b91d0f7d9
Public Version Date
September 01, 2020
Public Version Number
5
DI Record Publish Date
June 27, 2018
Package DI Number
20884527021281
Quantity per Package
100
Contains DI Package
10884527021284
Package Discontinue Date
September 01, 2020
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |