EvacuCart - Portable Cart for Smoke Evacuators - Buffalo Filter

Duns Number:787855907

Device Description: Portable Cart for Smoke Evacuators

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More Product Details

Catalog Number

-

Brand Name

EvacuCart

Version/Model Number

ETC01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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"

Yes

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 Details

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Device Record Status

Public Device Record Key

c43aa854-b17f-4e57-ba87-ff8f272bc611

Public Version Date

April 22, 2022

Public Version Number

3

DI Record Publish Date

January 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BUFFALO FILTER" Characteristics
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