AccessGUDID - DEVICE: Invotec Single Channel Electrode (00818501020034)

GUDID

Device Identifier (DI) Information

Brand Name: Invotec Single Channel Electrode
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 29-80500W
Company Name: INVOTEC INTERNATIONAL, INC.

Primary DI Number: 00818501020034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622812592 *Terms of Use

Device Description: Invotec Single Channel Electrode, Wrap Around 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62208	Electromyographic endotracheal tube electrode	A sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETN	Stimulator, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122040	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b0b88a6-5914-4655-b6da-507bb41f7d27
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 03, 2017