Duns Number:305656662
Device Description: SCT 2100 shower change table, coated canvas, lying surface 21.7'' x 65'', with safety rail SCT 2100 shower change table, coated canvas, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted
Catalog Number
R8425418000
Brand Name
SCT 2100
Version/Model Number
R8425418
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
INT
Product Code Name
Plinth
Public Device Record Key
97c9576c-cabd-4e34-8d70-ef94619b8331
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 |