Duns Number:557815751
Device Description: The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image t The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Catalog Number
-
Brand Name
Cassette 35cmx43cm(IP 35cmx43cm)Kit
Version/Model Number
CA04
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
db1f545a-04a3-4c40-91b4-a4c731c7d0e2
Public Version Date
February 07, 2020
Public Version Number
5
DI Record Publish Date
August 02, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |