Duns Number:314629130
Device Description: Basic diagnostic x-ray system table, non-powered
Catalog Number
7034-0-0000
Brand Name
PROGNOST XS
Version/Model Number
table top 196,3x65,5cm composite fiber
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 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
KXJ
Product Code Name
Table, Radiologic
Public Device Record Key
6ca81dfa-eed5-4b2d-84bf-d5fcf6a6d51b
Public Version Date
December 14, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2020
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |