Duns Number:627879687
Device Description: The VIA Procedure Kit custom includes Gauze, VIA basin, enzymatic sponge, lubricating jell The VIA Procedure Kit custom includes Gauze, VIA basin, enzymatic sponge, lubricating jelly, BioGuard Air Water cleaning adapter and BioShield.
Catalog Number
00717394
Brand Name
VIA
Version/Model Number
00717394
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
e094f4da-1040-4c8b-ac57-16faf32d8223
Public Version Date
October 15, 2021
Public Version Number
1
DI Record Publish Date
October 07, 2021
Package DI Number
10724995216594
Quantity per Package
20
Contains DI Package
00724995216597
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 |