Duns Number:305656662
Device Description: SCT 2100 shower table, outer measurements 35.4'' x 70.9'', lying surface in coated canvas, SCT 2100 shower table, outer measurements 35.4'' x 70.9'', lying surface in coated canvas, 21.7'' x 65'', white. With safety rail and water collection tray, foldable, electrically height adjustable with wired remote control, wall-mounted
Catalog Number
R8591418000
Brand Name
SCT 2000
Version/Model Number
R8591418
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
INQ
Product Code Name
Table, Powered
Public Device Record Key
94115c1c-c35d-4074-a04c-59465745d0ff
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 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 |