Duns Number:071595540
Device Description: ViroSafe Pre-Filter Smoke Evacuation Pre-Filter
Catalog Number
BFPF7/8-10
Brand Name
VIROSAFE
Version/Model Number
BFPF7/8-10
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
a22d9fc7-97b1-4093-bcbc-43367b1084ae
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
July 12, 2020
Package DI Number
30845854081222
Quantity per Package
10
Contains DI Package
20845854081225
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 |