Duns Number:071595540
Device Description: StrykeVac 3 Smoke Evacuation Filter with 1/4 Inch (6.4mm), 3/8 Inch (9.5m), and 7/8 Inch ( StrykeVac 3 Smoke Evacuation Filter with 1/4 Inch (6.4mm), 3/8 Inch (9.5m), and 7/8 Inch (22mm) Ports
Catalog Number
VSSV304
Brand Name
NA
Version/Model Number
VSSV304
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
0ef2eee7-8352-433a-973c-3dc3e3ae2868
Public Version Date
July 03, 2020
Public Version Number
1
DI Record Publish Date
June 25, 2020
Package DI Number
30845854081635
Quantity per Package
4
Contains DI Package
20845854081638
Package Discontinue Date
-
Package Status
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 | 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 |