Duns Number:315304071
Device Description: D CAMERA CONTROLLER for connection of sensor endoscopes, Output: 1x HDMI, 1x SDI, Capturi D CAMERA CONTROLLER for connection of sensor endoscopes, Output: 1x HDMI, 1x SDI, Capturing video/images on USB, Resolution: 1920x1080 (HDMI, SDI), 1280x1024 (HDMI), Revolutions: 100-240VAC, 50/60Hz, Dim. (wxhxd) 200x60x220mm
Catalog Number
5522101
Brand Name
ENDOCAM
Version/Model Number
5522101
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
K211332
Product Code
FET
Product Code Name
Endoscopic video imaging system/component, gastroenterology-urology
Public Device Record Key
3c9654be-9387-4eaa-b7e9-81c98cd6405d
Public Version Date
October 29, 2021
Public Version Number
1
DI Record Publish Date
October 21, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |