Duns Number:071595540
Device Description: ViroSafe 6 Twin Port Filter Smoke Evacuation Filter Twin male ports - 7/8 in (22mm)
Catalog Number
VS06T01
Brand Name
VIROSAFE
Version/Model Number
VS06T01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2022
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
-
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
K930041
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
5bfa9ef5-541d-41fd-b7cf-e8db8e2d3a73
Public Version Date
June 08, 2022
Public Version Number
2
DI Record Publish Date
June 23, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |