Duns Number:627879687
Device Description: The VIA Procedure Kit-custom includes transport pad, gauze, solidifier, basin, enzymatic s The VIA Procedure Kit-custom includes transport pad, gauze, solidifier, basin, enzymatic sponge, lubricating jelly, suction tubing, DuoSwift cleaning brush, valve-control head brush, and BioShield biopsy valve.
Catalog Number
00717329
Brand Name
VIA
Version/Model Number
00717329
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
55eafc75-bb72-4337-acf7-ea73e3b3a1fb
Public Version Date
December 07, 2020
Public Version Number
3
DI Record Publish Date
August 24, 2020
Package DI Number
10724995203044
Quantity per Package
12
Contains DI Package
00724995203047
Package Discontinue Date
September 15, 2020
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 |