FDA.reportPublic FDA data

OtoSight Speculum Tip Combination Package

Primary DI
00850013784110
Brand
OtoSight Speculum Tip Combination Package
Company
Photonicare, Inc.
Model
Combo
Device description
Combination Package for shipping containing QTY 100 Large OtoSight Speculum Tips (Unit of Use DI #00850013784073) packaged in 5 20-packs (DI#10850013784070) and QTY 100 Standard OtoSight Speculum Tips (Unit of Use DI #00850013784080) packaged in 5 20-packs (DI#10850013784087).
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191804000TOMi ScopePhotonicare, Inc.2019-12-05QJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013784110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013784110008500137841108500137841100850013784110

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, single-useA semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078873691
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013784004OtoSight Middle Ear Scope34R2022-04-15
00850013784127OtoSight Middle Ear Scope with Battery34R2023-08-20
00850013784134OtoSight Middle Ear Scope with Battery34R2023-08-20
10850013784070Large OtoSight Speculum Tip QTY 20Large2022-04-15
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
00850013784127OtoSight Middle Ear Scope with BatteryPhotonicare, Inc.QJG2023-08-20
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
00850013784097Large OtoSight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15
10850013784087Standard Otosight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15