Duns Number:314101218
Device Description: Image-intensified fluoroscopic x-ray system
Catalog Number
706100
Brand Name
ProxiGiagnost N90
Version/Model Number
9890-010-70221
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JAA
Product Code Name
System, x-ray, fluoroscopic, image-intensified
Public Device Record Key
86b3d965-bae0-4263-be64-5335000cf65a
Public Version Date
October 11, 2021
Public Version Number
3
DI Record Publish Date
May 09, 2018
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 | 173 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |