Duns Number:305656662
Device Description: PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, white. Electrically he PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, white. Electrically height adjustable, manually sideways adjustable, for fitting to horizontal wall track
Catalog Number
R7864000
Brand Name
PLUS
Version/Model Number
R7864
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
INN
Product Code Name
Chair, Adjustable, Mechanical
Public Device Record Key
a7d08f06-10ba-4ea0-8739-58bc5276a6f6
Public Version Date
June 22, 2021
Public Version Number
1
DI Record Publish Date
June 14, 2021
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 | 319 |