Duns Number:305656662
Device Description: CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safet CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safety rail and body belt, foldable, fixed height, wall-mounted
Catalog Number
R8455512000
Brand Name
CT 5000
Version/Model Number
R8455512
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
INT
Product Code Name
Plinth
Public Device Record Key
bc8fd76c-1397-42f8-865b-508514c0ab16
Public Version Date
December 09, 2021
Public Version Number
1
DI Record Publish Date
December 01, 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 |