AccessGUDID - DEVICE: Neurosign Lantern Laryngeal Electrode 8/9mm (05060229531384)

GUDID

Device Identifier (DI) Information

Brand Name: Neurosign Lantern Laryngeal Electrode 8/9mm
Version or Model: 4200-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THE MAGSTIM COMPANY LIMITED

Primary DI Number: 05060229531384
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 500375274 *Terms of Use

Device Description: To fit 8 or 9mm endotracheal tubes

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f58219a-0cf4-456d-aea5-38b5035d6f8c
Public Version Date: August 30, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016