Duns Number:627879687
Device Description: The VIA Procedure Kit - custom includes gauze, biohazard sticker, water detergent label, s The VIA Procedure Kit - custom includes gauze, biohazard sticker, water detergent label, simethicone and water label, Chux pad, basins, enzymatic sponge, lubricating jelly, BioGuard 4-pc kit, and BioGuard AW cleaning adapter.
Catalog Number
00717342
Brand Name
VIA
Version/Model Number
00717342
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
3d30fc05-9f57-4b90-9dae-fcede08c704c
Public Version Date
June 06, 2022
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
10724995203686
Quantity per Package
18
Contains DI Package
00724995203689
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 |