Duns Number:627879687
Device Description: The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, syringe, biohazard sticker, lubricating jelly, gown, DuoSwift combination squeegee brush, and BioGuard air water and suction valves 4 piece kit.
Catalog Number
00717113
Brand Name
VIA
Version/Model Number
00717113
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
NWW
Product Code Name
Hysteroscope accessories
Public Device Record Key
40ea6c13-2482-4857-b178-d82383a6f66f
Public Version Date
February 03, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2018
Package DI Number
10816765015015
Quantity per Package
12
Contains DI Package
00816765015018
Package Discontinue Date
February 03, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |