Duns Number:083171244
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 digitally adjust the image quality and orientation.
Catalog Number
ICB/ASX15
Brand Name
Aurora Surgiscope System
Version/Model Number
ICB/ASX15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201840
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
a2f9c98a-feb9-4b3d-9787-80ff8ddcb569
Public Version Date
June 02, 2022
Public Version Number
3
DI Record Publish Date
May 18, 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |