Duns Number:787855907
Device Description: Smoke Evacuation In-Line Filter (single use)
Catalog Number
-
Brand Name
Buffalo Filter
Version/Model Number
BILF100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 18, 2019
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"
Yes
For Single-Use
Yes
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
K930450,K930450
Product Code
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
9ba91440-dff8-46a3-af04-795219bb7922
Public Version Date
January 21, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10851136002218
Quantity per Package
10
Contains DI Package
00851136002211
Package Discontinue Date
January 18, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |