Madsen 8-67-41300

GUDID 05713315009013

Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100

Gn Otometrics A/S

Impedance audiometer

• Primary Device ID: 05713315009013
• NIH Device Record Key: d15987c0-c800-4b74-9688-f6d278fa38f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Madsen
• Version Model Number: 1012 OTOflex Cavity set
• Catalog Number: 8-67-41300
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315009013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033645

FDA Product Code

• ETY: Tester, Auditory Impedance

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: 2021-08-19
• Device Publish Date: 2021-08-11

On-Brand Devices [Madsen]

• 05713315009228: Madsen A450 audiometer
• 05713315009204: Madsen Astera2 clinical audiometer
• 05713315009013: Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100