Lucid Hearing ®

GUDID 00846430005358

Specialist Screener

ETYMOTIC RESEARCH, INC.

Otoacoustic emission system, battery-powered

• Primary Device ID: 00846430005358
• NIH Device Record Key: 92d16a22-bdfc-4003-8f1e-d4ce66eda88d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucid Hearing ®
• Version Model Number: ER36-LH-1
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430005358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150491

FDA Product Code

• EWO: Audiometer

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: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [Lucid Hearing ®]

• 00846430005365: Ear Probe
• 00846430005358: Specialist Screener