Duns Number:356774109
Device Description: Stationary x-ray system intended for obtaining radiographic images of various portions of Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Catalog Number
-
Brand Name
OMNERA 400T
Version/Model Number
0180
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
KPR
Product Code Name
System, X-Ray, Stationary
Public Device Record Key
699cad6c-271b-43cf-af4e-af8d60ebcc60
Public Version Date
December 08, 2021
Public Version Number
3
DI Record Publish Date
December 04, 2017
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. | 3 |