AccessGUDID - DEVICE: Romet (00860009460515)

GUDID

Device Identifier (DI) Information

Brand Name: Romet
Version or Model: R210
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fountain Head Marketing Inc.

Primary DI Number: 00860009460515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830442310 *Terms of Use

Device Description: After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The ROMET Electronic Larynx Model R210 Kit Includes: Full 2 Year Warranty - Including Drop On Hard Surface or In Liquid External Pitch & Volume Controls Larger, Ergonomic On/Off Button Polished Aluminum Barrel 2- 9V Lithium Batteries and "Smart" Charger Lanyard

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:	No
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?
30076	Voice amplification system	An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESE	Larynx, Artificial (Battery-Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9338665e-2154-41e6-9a2b-1815b93804a1
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023