Duns Number:071595540
Device Description: ViroSafe 12 Smoke Evacuation Filter Dual male ports - 7/8 in (22mm) or 1-1/4 in (32mm)
Catalog Number
VS12D01
Brand Name
VIROSAFE
Version/Model Number
VS12D01
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
-
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,K930041
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
492d3ff6-66ee-4748-95fc-d1993b347a52
Public Version Date
April 22, 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 |