Otoscan 043244

GUDID 05713315011054

1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription

Gn Otometrics A/S

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• Primary Device ID: 05713315011054
• NIH Device Record Key: 6ac57cc5-0957-4292-bb46-6811654b76b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otoscan
• Version Model Number: 043244
• Catalog Number: 043244
• 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: 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	05713315011054 [Primary]

FDA Product Code

• ERA: Otoscope

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: 2024-04-23
• Device Publish Date: 2024-04-15

On-Brand Devices [Otoscan]

• 05713315010699: 1093,OTOSCAN Bundle – Scanner & Headset without laptop
• 05713315011054: 1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription