Duns Number:532199478
Catalog Number
153-0006
Brand Name
VS3 Endoscope 4mm, Elbow, 0°, Wide FOV
Version/Model Number
VS3-NE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 2022
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
K131434
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
1cce1564-eb3c-4d21-930e-fdd9272392f6
Public Version Date
June 13, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |