Duns Number:185444825
Device Description: Footswitch, Mega Vac Smoke Evacuator Footswitch
Catalog Number
2160J
Brand Name
MEGA VAC FOOTSWITCH
Version/Model Number
2160J
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 18, 2021
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
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
-
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
a6005fd8-cdc5-4caf-a567-920f9981d32a
Public Version Date
October 19, 2021
Public Version Number
7
DI Record Publish Date
September 04, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 219 |