Aurical

GUDID 05713315009211

Aurical Aud audiometer

Gn Otometrics A/S

Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated Tone audiometer, semi-automated

• Primary Device ID: 05713315009211
• NIH Device Record Key: 0edb9fd0-92f1-4876-8975-d8b1c8d279f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurical
• Version Model Number: 8-04-14530-CA
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315009211 [Primary]

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: 2021-07-09
• Device Publish Date: 2021-07-01

Devices Manufactured by Gn Otometrics A/S

• 05713315011054 - Otoscan: 2024-04-23 1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription
• 05713315008726 - Disposable Snap Electrodes (3 pack): 2023-12-18
• 05713315008733 - Disposable Snap Electrodes (25 x 3 pack): 2023-12-18
• 05713315010279 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315010286 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315010293 - Madsen A450: 2023-08-03 1081 Madsen A450
• 05713315009464 - Madsen Zodiac: 2023-07-12 1096 Zodiac PC QC
• 05713315010699 - Otoscan: 2023-05-19 1093,OTOSCAN Bundle – Scanner & Headset without laptop