AccessGUDID - DEVICE: N/A (04250307612055)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 530955
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: inomed Medizintechnik GmbH

Primary DI Number: 04250307612055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 340782259 *Terms of Use

Device Description: Laryngeal Electrode select + Needle electrode for tube with 6-7 mm inner diameter

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7a9c756-23bf-4495-b7f6-64cbd3504f65
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 02, 2025