DEVICE: OtoSight Middle Ear Scope (00850013784004)
Device Identifier (DI) Information
OtoSight Middle Ear Scope
34R
In Commercial Distribution
Photonicare, Inc.
34R
In Commercial Distribution
Photonicare, Inc.
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. It is available with and without a battery.
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? |
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44929 | Otoscope, endoscopic |
An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QJG | Device System, Imaging, Tympanic Membrane And Middle Ear |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K191804 | 000 |
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
6393b361-3a2a-445b-8002-56cf8f8d84b3
March 31, 2025
4
April 15, 2022
March 31, 2025
4
April 15, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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00850013784035 | 1 | 00850013784004 | In Commercial Distribution | Shipping Box | |
00850013784141 | 1 | 00850013784004 | In Commercial Distribution | Box with WA Adapter | |
00850013784172 | 1 | 00850013784004 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18664113277
support@photoni.care
support@photoni.care