Duns Number:627879687
Device Description: The VIA Procedure Kit custom includes Take-out Transport Pad, gauze, VIA basin, Surgilube, The VIA Procedure Kit custom includes Take-out Transport Pad, gauze, VIA basin, Surgilube, and BioGuard 4-piece kit.
Catalog Number
00717406
Brand Name
VIA
Version/Model Number
00717406
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 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
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
NWU
Product Code Name
Endoscope introducer kit
Public Device Record Key
2f2a00a6-36f3-4d9e-8dd0-bb8773cb8c82
Public Version Date
June 06, 2022
Public Version Number
2
DI Record Publish Date
September 15, 2021
Package DI Number
10724995216457
Quantity per Package
20
Contains DI Package
00724995216450
Package Discontinue Date
June 03, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |