Otometrics

GUDID 05713315002304

Gn Otometrics A/S

Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer

• Primary Device ID: 05713315002304
• NIH Device Record Key: 6fcf2c8e-06b2-4956-bc4b-f8f775a49399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otometrics
• Version Model Number: Adult IPSI probeset, HL. Calibration: HL
• 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: 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	05713315002304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910247

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: 2019-05-01
• Device Publish Date: 2019-04-23

On-Brand Devices [Otometrics]

• 05713315005978: Combined TDH-39 and inserts
• 05713315005961: With inserts
• 05713315005954: With TDH-39
• 05713315005862: 1085, Face Cushion 2 Box Kit
• 05713315002304: Adult IPSI probeset, HL. Calibration: HL
• 05713315003295: Goggle face cushion kit
• 05713315008467: 1085, FACE PAD ASSEMBLY KIT V2
• 05713315008566: 1085, FACE CUSHION 2 ASM KIT
• 05713315008443: 1085, STRAP ASSEMBLY