FDA.reportPublic FDA data

OtoSight Middle Ear Scope with Battery

Primary DI
00850013784127
Brand
OtoSight Middle Ear Scope with Battery
Company
Photonicare, Inc.
Model
34R
Device description
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.
Published
2023-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJGDevice System, Imaging, Tympanic Membrane And Middle Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJGDevice System, Imaging, Tympanic Membrane And Middle EarRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013784134PackageGS11In Commercial Distribution
00850013784158PackageGS11In Commercial Distribution
00850013784127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013784134008500137841348500137841340850013784134
00850013784158008500137841588500137841580850013784158
00850013784127008500137841278500137841270850013784127

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn 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.

Contacts#

Phone, Email table
PhoneEmail
18664113277support@photoni.care

Regulatory Flags#

DUNS number
078873691
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013784004OtoSight Middle Ear Scope34R2022-04-15
00850013784134OtoSight Middle Ear Scope with Battery34R2023-08-20
10850013784070Large OtoSight Speculum Tip QTY 20Large2022-04-15
00850013784110OtoSight Speculum Tip Combination PackageCombo2022-04-15
00850013784097Large OtoSight Speculum Tip QTY 20Large2022-04-15
10850013784087Standard Otosight Speculum Tip QTY 20Standard2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013784134OtoSight Middle Ear Scope with BatteryPhotonicare, Inc.QJG2023-08-20
10850013784070Large OtoSight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15
00850013784004OtoSight Middle Ear ScopePhotonicare, Inc.QJG2022-04-15
00850013784110OtoSight Speculum Tip Combination PackagePhotonicare, Inc.QJG2022-04-15
00850013784097Large OtoSight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15
10850013784087Standard Otosight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15