Duns Number:874709348
Device Description: REHAB SHOWER COMMODE CHAIR,PADDED SEAT,FOOTREST,24" REAR WHEELS,WT LIMIT 230 LBS
Catalog Number
-
Brand Name
DALTON REHAB SHOWER COMMODE CHAIR
Version/Model Number
BS-SHC931M
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)
-
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
c1af8b5d-5d78-41d3-8f79-a9da941563b8
Public Version Date
May 19, 2020
Public Version Number
1
DI Record Publish Date
May 11, 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 | 66 |
2 | A medical device with a moderate to high risk that requires special controls. | 57 |