Duns Number:259777209
Device Description: MCT SEAT - CLASSIC RAIL
Catalog Number
-
Brand Name
TRZ-CG POWER POSITIONING SYSTEM
Version/Model Number
BR-CLSC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 05, 2021
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
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
a36b13a8-09c7-4286-9a9a-8b9932a1bc7d
Public Version Date
August 10, 2021
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 176 |