Duns Number:793169512
Device Description: X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F
Catalog Number
8624181
Brand Name
DRX-Compass X-ray System
Version/Model Number
DRX-Compass X-ray System
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201373
Product Code
KPR
Product Code Name
System, x-ray, stationary
Public Device Record Key
562804f4-b770-455e-a6ff-2d7b89a4917c
Public Version Date
January 19, 2022
Public Version Number
1
DI Record Publish Date
January 11, 2022
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 |