Duns Number:071595540
Device Description: ViroSafe VisiClear Filter Smoke Evacuation Filter 3-port - 1/4 in (6.4mm), 3/8 in (9.5mm), ViroSafe VisiClear Filter Smoke Evacuation Filter 3-port - 1/4 in (6.4mm), 3/8 in (9.5mm), and 7/8 in (22mm)
Catalog Number
VS135
Brand Name
VIROSAFE VISICLEAR
Version/Model Number
VS135
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
-
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
afc6d789-6b2a-4baa-8e5d-a5cedbaaa7dc
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
July 17, 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 |