Otometrics 8-35-39300

GUDID 05713315008467

Gn Otometrics A/S

Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph

• Primary Device ID: 05713315008467
• NIH Device Record Key: 414220ce-d16b-43e2-bc51-9253a9d3d18d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otometrics
• Version Model Number: 1085, FACE PAD ASSEMBLY KIT V2
• Catalog Number: 8-35-39300
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315008467 [Primary]
GS1	05713315008498 [Package]; Contains: 05713315008504; Package: Carton [10 Units]; In Commercial Distribution
GS1	05713315008504 [Package]; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122550

FDA Product Code

• GWN: Nystagmograph

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: 2020-05-26
• Device Publish Date: 2020-05-18

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