MEGA VAC FOOTSWITCH - Footswitch, Mega Vac Smoke Evacuator Footswitch - MEGADYNE MEDICAL PRODUCTS, INC.

Duns Number:185444825

Device Description: Footswitch, Mega Vac Smoke Evacuator Footswitch

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More Product Details

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

Product Characteristics

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 Details

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGADYNE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 219