Duns Number:132016168
Device Description: Rehab Shower Commode Chair Padded Seat Oval Cutout 14 1/2" & 17 1/2"
Catalog Number
90835070J
Brand Name
Everest & Jennings
Version/Model Number
90835070J
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
INB
Product Code Name
Attachment, Commode, Wheelchair
Public Device Record Key
1a5593ec-e560-4a18-b2c8-71f9bfe6f585
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
December 01, 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 |