Duns Number:793169512
Device Description: PACKED, 3543 DETECTOR, DRX PLUS
Catalog Number
AL6750
Brand Name
DRX Plus 3543 Detector
Version/Model Number
DRX Plus 3543 Detector
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
K150766
Product Code
MQB
Product Code Name
Solid state x-ray imager (flat panel/digital imager)
Public Device Record Key
3943dec3-819f-48ab-b716-9c51a373a985
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 04, 2021
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 |