DEVICE: Tyto Otoscope (07290016672022)
Device Identifier (DI) Information
Tyto Otoscope
Tyto Otoscope
In Commercial Distribution
800-00002
TYTO CARE LTD
Tyto Otoscope
In Commercial Distribution
800-00002
TYTO CARE LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12849 | Otoscope, direct |
An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ERA | Otoscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
59644d35-8660-4670-a500-fef12344acac
May 10, 2021
4
December 22, 2016
May 10, 2021
4
December 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
17290016672029 | 1 | 07290016672022 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+972722210750
amirh@tytocare.com
amirh@tytocare.com