Duns Number:102370137
Device Description: Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
Catalog Number
Digital Detector Holder
Brand Name
Trans-Former
Version/Model Number
[T][#]-[Z]
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
IXY
Product Code Name
Holder, Radiographic Cassette, Wall-Mounted
Public Device Record Key
bd023470-f914-4896-a406-58e28e8d7663
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
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 | 2 |