Ceretone

GUDID 20860010331099

OTC Hearing Aid

Audicon Corporation

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 20860010331099
• NIH Device Record Key: 8688f930-d230-4c10-a808-a5ed488beeb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceretone
• Version Model Number: Core one
• Company DUNS: 118836847
• Company Name: Audicon Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010331095 [Primary]
GS1	10860010331092 [Package]; Contains: 00860010331095; Package: Inner Pack [2 Units]; In Commercial Distribution
GS1	20860010331099 [Package]; Contains: 00860010331095; Package: Case [40 Units]; In Commercial Distribution
GS1	30860010331096 [Package]; Contains: 10860010331092; Package: Csae [20 Units]; In Commercial Distribution

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, Over The Counter

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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [Ceretone]

• 00860010331026: OTC Rechargeable Hearing Aid
• 10850065321018: OTC Hearing Aid
• 20860010331099: OTC Hearing Aid
• 10860010331030: OTC Hearing Aid