Tyto Otoscope 800-00002

GUDID 07290016672022

The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and still images of the external ear canal and tympanic membrane, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations.

TYTO CARE LTD

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• Primary Device ID: 07290016672022
• NIH Device Record Key: 59644d35-8660-4670-a500-fef12344acac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyto Otoscope
• Version Model Number: Tyto Otoscope
• Catalog Number: 800-00002
• Company DUNS: 649125325
• Company Name: TYTO CARE LTD
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672022 [Primary]
GS1	17290016672029 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• ERA: Otoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-08
• Device Publish Date: 2016-12-22

On-Brand Devices [Tyto Otoscope]

• 07290016672206: The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and
• 07290016672022: The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and
• 07290016672381: The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and
• 07290016672350: The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and
• 07290016672411: The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and