Duns Number:202887311
Device Description: Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 80kW, 400V
Catalog Number
-
Brand Name
CMP 200 DR
Version/Model Number
VZW2556RD2
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
IZO
Product Code Name
Generator, High-Voltage, X-Ray, Diagnostic
Public Device Record Key
e4bcc362-af89-4a7f-9bcf-9f9cd8ddc7fe
Public Version Date
October 14, 2020
Public Version Number
2
DI Record Publish Date
July 24, 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 | 34 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |