Link by Eargo

GUDID 00850010429670

Link by Eargo Large Eartips (Open & Closed)

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429670
• NIH Device Record Key: a221e72c-9543-48fb-affb-5cff00e9b3b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Link by Eargo
• Version Model Number: 99-0174-003
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010429670 [Primary]

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, 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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [Link by Eargo]

• 00850010429670: Link by Eargo Large Eartips (Open & Closed)
• 00850010429663: Link by Eargo Medium Eartips (Open & Closed)
• 00850010429656: Link by Eargo Small Eartips (Open & Closed)
• 00850010429649: Link by Eargo