eXciteOSA

GUDID 05060627480017

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

SIGNIFIER MEDICAL TECHNOLOGIES LIMITED

Sleep-disordered breathing tongue electrical stimulator

• Primary Device ID: 05060627480017
• NIH Device Record Key: 4a1ba476-84f7-4ad1-b83b-050713f6b6f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eXciteOSA
• Version Model Number: 801600001
• Company DUNS: 220701035
• Company Name: SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060627480017 [Primary]

FDA Product Code

• QNO: Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [eXciteOSA]

• 05060627480024: eXciteOSA control unit. eXciteOSA is intended for the reduction of primary snoring and obstructi
• 05060627480017: eXciteOSA mouthpiece. eXciteOSA is intended for the reduction of primary snoring and obstructiv