nuance audio

GUDID 08059820279761

LUXOTTICA GROUP SPA

Air-conduction hearing aid, spectacle

• Primary Device ID: 08059820279761
• NIH Device Record Key: b2996e0b-e774-43f1-b5f4-eda0ee3b2f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nuance audio
• Version Model Number: AW5002348
• Company DUNS: 436825376
• Company Name: LUXOTTICA GROUP SPA
• 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	08059820279761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243150

FDA Product Code

• SCR: Air-Conduction Hearing Aid Software

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: 2025-02-13
• Device Publish Date: 2025-02-05

On-Brand Devices [nuance audio]

• 08059820279921: AW5004656
• 08059820279914: AW5004556
• 08059820279907: AW5004456
• 08059820279860: AW5004356
• 08059820279792: AW5002648
• 08059820279785: AW5002548
• 08059820279778: AW5002448
• 08059820279761: AW5002348
• 08059820279655: AW5001454
• 08056262013229: WAW000001
• 08059820279679: AW5001654
• 08059820279662: AW5001554
• 08059820279648: AW5001354