Duns Number:080935429
Device Description: Pre-TENS Skin Prep Wipes
Catalog Number
MS71000
Brand Name
Uni-Patch
Version/Model Number
MS71000
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)
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
28d50192-61b1-42d0-8da6-94cb128591e1
Public Version Date
March 11, 2019
Public Version Number
3
DI Record Publish Date
June 27, 2018
Package DI Number
20884527007544
Quantity per Package
50
Contains DI Package
10884521210738
Package Discontinue Date
-
Package Status
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 |