Duns Number:735575941
Device Description: Revitive Arthritis Knee Pads
Catalog Number
2939
Brand Name
Revitive Arthritis Knee Pads
Version/Model Number
2939
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
c451ad44-e244-4bd6-97a2-53b4a6e81520
Public Version Date
May 17, 2021
Public Version Number
3
DI Record Publish Date
July 28, 2020
Package DI Number
05060217493588
Quantity per Package
8
Contains DI Package
05060217493571
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |