Duns Number:080909607
Device Description: The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers the video t The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers the video to a Display Monitor, and allows the user to turn knobs that digitally adjust the image quality and orientation.
Catalog Number
IMAGE_CONTROL_BOX
Brand Name
AURORA Surgiscope System
Version/Model Number
Image Control Box
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182211
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
ba267bdd-0961-4f12-8b9c-bf0d9725f042
Public Version Date
October 26, 2022
Public Version Number
7
DI Record Publish Date
January 22, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |