Single Use Eartips

GUDID 00846430004146

Eartip 10mm 100pkg

ETYMOTIC RESEARCH, INC.

Audiometric ear tip

• Primary Device ID: 00846430004146
• NIH Device Record Key: 11ec0517-2536-4f0c-a049-d5ec8f0bf4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Eartips
• Version Model Number: ER10D-T10
• Company DUNS: 115380859
• Company Name: ETYMOTIC RESEARCH, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430004146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930553

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by ETYMOTIC RESEARCH, INC.

• 00846430006027 - LucidHearing: 2025-04-17 BHA-Tala-MFI-OTC 20128-BHA
• 00846430006034 - LucidHearing: 2025-04-17 BHA-Tala-Android-OTC 20138-BHA
• 00846430005846 - Lucid Audio: 2024-11-07 TALA Android EARPIECE LEFT
• 00846430005853 - Lucid Audio: 2024-11-07 TALA Android EARPIECE RIGHT
• 00846430005877 - Lucid Audio: 2024-11-07 Tala MFI Earpiece LEFT
• 00846430005884 - Lucid Audio: 2024-11-07 Tala MFI Earpiece RIGHT
• 00846430006003 - Lucid Audio: 2024-08-27 Accent Bluetooth rechargeable 1401 - Android WH - 32 channel *Sam's Club 20218
• 00846430006010 - Lucid Audio: 2024-08-27 Accent Bluetooth rechargeable 1501 - MFI WH - 32 channel *Sam's Club 20219