Duns Number:627879687
Device Description: The VIA Procedure Kit custom includes Gauze, simethicone and water label, Basin, enzymatic The VIA Procedure Kit custom includes Gauze, simethicone and water label, Basin, enzymatic sponge, Lubricating Jelly, BioGuard Air Water cleaning adapter, Transport Pad, biohazard sticker and DEFENDO 4 piece Kit for Olympus Endoscopes.
Catalog Number
00717379
Brand Name
VIA
Version/Model Number
00717379
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
69c6ccbe-644b-42d8-a2c6-5a8e225fddcb
Public Version Date
July 21, 2022
Public Version Number
5
DI Record Publish Date
August 27, 2021
Package DI Number
10724995215894
Quantity per Package
18
Contains DI Package
00724995215897
Package Discontinue Date
February 25, 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 |