Tyto Otoscope - The Tyto Otoscope is an electronic otoscope that - TYTO CARE LTD

Duns Number:649125325

Device Description: The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof vide The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof video and still images of the external ear canal and tympanic membrane, whereby aclinician at one location on an IP network can view images and videos of a patient on site orat a different location on the IP network with the signal carried on an IP connection betweenthe two locations.

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More Product Details

Catalog Number

800-00020

Brand Name

Tyto Otoscope

Version/Model Number

Tyto Otoscope, Zamak, BLK, US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ERA

Product Code Name

Otoscope

Device Record Status

Public Device Record Key

3ed117bd-819a-44b1-8cc9-27e3633fac02

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

September 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYTO CARE LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 5