Traxtion - The Traxtion hexagonal snare is an - US Endoscopy

Duns Number:627879687

Device Description: The Traxtion hexagonal snare is an electrosurgical device used to grasp, dissect and trans The Traxtion hexagonal snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.

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More Product Details

Catalog Number

00711113

Brand Name

Traxtion

Version/Model Number

00711113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

FDI

Product Code Name

SNARE, FLEXIBLE

Device Record Status

Public Device Record Key

97a70f54-ea90-4f7b-ac2b-fcdf112720f4

Public Version Date

November 10, 2020

Public Version Number

2

DI Record Publish Date

March 19, 2020

Additional Identifiers

Package DI Number

10724995182608

Quantity per Package

10

Contains DI Package

00724995182601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902