Duns Number:627879687
Device Description: The VIA Procedure Kit custom includes gauze, Chux pad, basin, enzymatic sponge, lubricatin The VIA Procedure Kit custom includes gauze, Chux pad, basin, enzymatic sponge, lubricating jelly, suction tubing, and Double-Header channel valve brush.
Catalog Number
00717434
Brand Name
VIA
Version/Model Number
00717434
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
1ff9483a-faf8-420c-95e1-f0b7f5123d15
Public Version Date
February 15, 2022
Public Version Number
1
DI Record Publish Date
February 07, 2022
Package DI Number
10724995217348
Quantity per Package
18
Contains DI Package
00724995217341
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 |