Duns Number:080935429
Device Description: Compression Wrap
Catalog Number
MV75150
Brand Name
Uni-Patch
Version/Model Number
MV75150
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
-
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
ee935e3e-c0c7-4275-8e09-7e354d2f8626
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 29, 2018
Package DI Number
90884521190289
Quantity per Package
100
Contains DI Package
10884521190283
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 |