Duns Number:080909607
Device Description: The AURORA Surgiscope System consists of two components: sterile, single use, neurologica The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator.
Catalog Number
AURORA Surgiscope-13
Brand Name
AURORA Surgiscope
Version/Model Number
AURORA Surgiscope-13
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 24, 2019
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
Yes
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
-
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
ca060349-7e29-42cd-b20e-e4e54e08abeb
Public Version Date
October 13, 2021
Public Version Number
6
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 |