Duns Number:627879687
Device Description: The VIA Procedure Kit custom includes solidifier, BioShield Biopsy Valve, DEFENDO 4 piece The VIA Procedure Kit custom includes solidifier, BioShield Biopsy Valve, DEFENDO 4 piece Kit for Olympus Endoscopes. and Revital-Ox bedside concentrate.
Catalog Number
00717414
Brand Name
VIA
Version/Model Number
00717414
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
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
d0f7fba1-9484-4b0d-a6a8-20b1b126fed7
Public Version Date
July 21, 2022
Public Version Number
3
DI Record Publish Date
October 25, 2021
Package DI Number
10724995216655
Quantity per Package
18
Contains DI Package
00724995216658
Package Discontinue Date
-
Package Status
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 |