Duns Number:315304071
Device Description: LOGIC HD CAMERA CONTROLLER touch screen, color display, compatible with core nova, Output LOGIC HD CAMERA CONTROLLER touch screen, color display, compatible with core nova, Output: 2x HDMI, Capturing images on USB, Resolution:1920 x 1200, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x157x436mm
Catalog Number
5525101
Brand Name
ENDOCAM
Version/Model Number
5525101
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
FET
Product Code Name
Endoscopic video imaging system/component, gastroenterology-urology
Public Device Record Key
b451e676-2102-45dd-85c2-ed24272a671a
Public Version Date
April 23, 2021
Public Version Number
8
DI Record Publish Date
July 21, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |