Duns Number:627879687
Device Description: The VIA procedure kit custom includes transport pad, gauze, biohazard sticker, water deter The VIA procedure kit custom includes transport pad, gauze, biohazard sticker, water detergent label, solidifier, Chux pad, basin, dry sponge, enzymatic sponge, lubricant jelly, syringe, DuoSwift brush, BioGuard 4-piece kit, BioGuard air water cleaning adapter, and O2 CO2 tubing.
Catalog Number
00717262
Brand Name
VIA
Version/Model Number
00717262
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
ece89363-0481-4748-aca4-888b85b2730a
Public Version Date
February 03, 2020
Public Version Number
3
DI Record Publish Date
December 18, 2019
Package DI Number
10816765016234
Quantity per Package
12
Contains DI Package
00816765016237
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 |