Sonite R Kit Binaural US 051-0231-H056

GUDID 07613389804164

Sonova AG

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 07613389804164
• NIH Device Record Key: aabe6ee4-73a0-4a6d-8256-344580f5b32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonite R Kit Binaural US
• Version Model Number: (beige)
• Catalog Number: 051-0231-H056
• Company DUNS: 480662550
• Company Name: Sonova AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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	07613389804164 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-13
• Device Publish Date: 2025-01-29

On-Brand Devices [Sonite R Kit Binaural US ]

• 07613389804164: (beige)
• 07613389808520: Sonite R Kit Binaural US (velvet black) - Primary DI number: 07613389808520 2x Sennheiser Sonite
• 07613389808513: Sonite R Kit Binaural US (silver gray) - Primary DI number: 07613389808513 2x Sennheiser Sonite
• 07613389808506: Sonite R Kit Binaural US (sandalwood) - Primary DI number: 07613389808506 2x Sennheiser Sonite R