Duns Number:111448069
Device Description: MVP Pro Recovery Package - Upper Body
Catalog Number
40410
Brand Name
NormaTec MVP Pro Upper Body Recovery Package
Version/Model Number
MVP Pro Recovery Package - Upper Body
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013436
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
73c9e480-25df-4222-b50b-bab9d6f1c21e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 202 |