AccessGUDID - DEVICE: eXciteOSA (05060627480017)

GUDID

Device Identifier (DI) Information

Brand Name: eXciteOSA
Version or Model: 801600001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIGNIFIER MEDICAL TECHNOLOGIES LIMITED

Primary DI Number: 05060627480017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 220701035 *Terms of Use

Device Description: eXciteOSA mouthpiece. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.

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?
63489	Sleep-disordered breathing tongue electrical stimulator	An electronic device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea), by improving tongue muscular tone achieved by applying a program of electrical stimulation to the tongue during waking hours. It consists of an electrode with various contact points designed to fit around the tongue, and a remote control unit which may be software on a mobile device. It is normally available [non-prescription] over-the-counter (OTC) as a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNO	Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

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: No
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: 4a1ba476-84f7-4ad1-b83b-050713f6b6f2
Public Version Date: August 22, 2024
Public Version Number: 1
DI Record Publish Date: August 14, 2024