Duns Number:793169512
Device Description: Q-FDR-VW-L VIEWORKS FXED DR CABINET LFT
Catalog Number
6571780
Brand Name
Q-FDR-VW-L
Version/Model Number
Q-FDR-VW-L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 22, 2019
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
IXY
Product Code Name
Holder, radiographic cassette, wall-mounted
Public Device Record Key
75d86f3e-034a-40a3-9808-870209b8c104
Public Version Date
October 25, 2019
Public Version Number
3
DI Record Publish Date
September 16, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |