Duns Number:627879687
Device Description: The VIA procedure kit-custom includes transport pad, gauze, basin, enzymatic sponge, Lubr The VIA procedure kit-custom includes transport pad, gauze, basin, enzymatic sponge, Lubricating Jelly, suction tubing, syringe, Double Header cleaning brush, BioGuard 2-piece kit, BioGuard Air Water cleaning adapter, BioShield biopsy valve, and ENDOGATOR Water Jet Connector for Olympus Endoscopes.
Catalog Number
00717315
Brand Name
VIA
Version/Model Number
00717315
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
ffa7cfb5-6e48-4be9-8477-c4ededcd8d1f
Public Version Date
July 18, 2022
Public Version Number
3
DI Record Publish Date
May 15, 2020
Package DI Number
10724995195035
Quantity per Package
12
Contains DI Package
00724995195038
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 |