Invotec Single Channel Electrode - Invotec Single Channel Electrode, Standard The - INVOTEC INTERNATIONAL, INC.

Duns Number:622812592

Device Description: Invotec Single Channel Electrode, Standard The Laryngeal Surface Electrode is intended to Invotec Single Channel Electrode, Standard The Laryngeal Surface Electrode is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

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More Product Details

Catalog Number

29-80500S

Brand Name

Invotec Single Channel Electrode

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K122040,K122040

Product Code Details

Product Code

ETN

Product Code Name

Stimulator, Nerve

Device Record Status

Public Device Record Key

697bb03f-2b98-4781-8142-7eb5ebeb0909

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

10818501020024

Quantity per Package

5

Contains DI Package

00818501020027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INVOTEC INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 69
U Unclassified 2