Duns Number:132016168
Device Description: Front Rigging w/ Heel Loop for EJ79X Series Transport Chairs, Silver Vein
Catalog Number
EJ79-FRSVA
Brand Name
Everest & Jennings
Version/Model Number
EJ79-FRSVA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMM
Product Code Name
Footrest, Wheelchair
Public Device Record Key
5b59bf01-32a9-4a8d-a34d-95d1f0d93949
Public Version Date
November 11, 2020
Public Version Number
1
DI Record Publish Date
November 03, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 202 |