Duns Number:713565195
Device Description: A cable used for connecting the flat panel sensor and the optional access point. This cabl A cable used for connecting the flat panel sensor and the optional access point. This cable is used for wired communication if wireless communication is not available.
Catalog Number
-
Brand Name
SE communication cable
Version/Model Number
DR-ID 1200 AP-SE CBL E
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
MQB
Product Code Name
Solid state x-ray imager (flat panel/digital imager)
Public Device Record Key
e04c1962-34f7-4c3d-bd81-c7f9ec3b9b8f
Public Version Date
May 29, 2020
Public Version Number
3
DI Record Publish Date
July 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |