Ceretone

GUDID 10860010331030

OTC Hearing Aid

Audicon Corporation

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 10860010331030
• NIH Device Record Key: d23448a9-5bb3-41f4-8e84-f5cfdec3922f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceretone
• Version Model Number: Beacon
• Company DUNS: 118836847
• Company Name: Audicon Corporation
• 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: 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	00860010331033 [Primary]
GS1	10860010331030 [Package]; Contains: 00860010331033; Package: Inner Pack [2 Units]; In Commercial Distribution
GS1	20860010331037 [Package]; Package: Case [20 Units]; In Commercial Distribution
GS1	30860010331034 [Package]; Contains: 00860010331033; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221052

FDA Product Code

• QUH: Self-Fitting Air-Conduction Hearing Aid, 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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [Ceretone]

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