Ceretone

GUDID 10860010331061

OTC Rechargeable Hearing Aid

Audicon Corporation

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 10860010331061
• NIH Device Record Key: 5c8ea5a4-d4eb-4694-94a3-eb566ae2353b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceretone
• Version Model Number: Solid
• 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: 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	00860010331064 [Primary]
GS1	10860010331061 [Package]; Contains: 00860010331064; Package: Inner Pack [2 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: 2025-01-17
• Device Publish Date: 2025-01-09

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• 10860010331030: OTC Hearing Aid
• 10860010331078: OTC Rechargeable Hearing Aid
• 10860010331061: OTC Rechargeable Hearing Aid
• 00860010331057: OTC Rechargeable Hearing Aid