Duns Number:627879687
Device Description: The VIA Procedure Kit - custom includes transport pad, gauze, biohazard sticker, basin, en The VIA Procedure Kit - custom includes transport pad, gauze, biohazard sticker, basin, enzymatic sponge, Lubricating Jelly, gowns, DEFENDO 4 piece Kit for Olympus Endoscopes, and BioGuard Air Water cleaning adapter.
Catalog Number
00717351
Brand Name
VIA
Version/Model Number
00717351
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
5ee162eb-c55f-440b-b023-be1af4721c79
Public Version Date
July 21, 2022
Public Version Number
2
DI Record Publish Date
June 24, 2022
Package DI Number
10724995214521
Quantity per Package
12
Contains DI Package
00724995214524
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 |