Side load bipolar electrode - (square fitting ; Fr26) - CHIRURGIE INNOVATION

Duns Number:264592326

Device Description: (square fitting ; Fr26)

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More Product Details

Catalog Number

MV2S

Brand Name

Side load bipolar electrode

Version/Model Number

Bipolar cutting loop / THICK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 08, 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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

FAS

Product Code Name

Electrode, Electrosurgical, Active, Urological

Device Record Status

Public Device Record Key

f9d5303f-1920-4b18-bf43-ce04e5eb95ea

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHIRURGIE INNOVATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19