Duns Number:627879687
Device Description: The VIA procedure kit custom includes gauze pads, VIA basin, enzymatic sponge, lubricating The VIA procedure kit custom includes gauze pads, VIA basin, enzymatic sponge, lubricating jelly, DuoSwift squeegee brush, BioGuard 3-piece kit, and BioGuard air water cleaning adapter.
Catalog Number
00717231
Brand Name
VIA
Version/Model Number
00717231
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2020
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
58bb663f-fb2b-412a-8e3b-570e30de36a3
Public Version Date
February 03, 2020
Public Version Number
3
DI Record Publish Date
August 26, 2019
Package DI Number
10816765015985
Quantity per Package
20
Contains DI Package
00816765015988
Package Discontinue Date
February 03, 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 |