FDA.reportPublic FDA data

OSSEOUS Ear Specula

Primary DI
08904461007160
Brand
OSSEOUS Ear Specula
Company
EON MEDITECH PRIVATE LIMITED
Model
EI0954
Device description
"Ear Specula is a funnel shaped with oblique end which inserted into the auditory canal of the ear, allowing to look at the ear canal and ear drum. "
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904461007160PackageGS1100In Commercial Distribution
08906039319545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904461007160089044610071608904461007160
08906039319545089060393195458906039319545

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6Millimeter
Outer Diameter35Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
930270428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9210921080Surgical DirectSurgical Direct, Inc.EPY2026-10-20
00190776435165MillenniumAvalign Technologies, Inc.EPY2026-10-16
00190776435172MillenniumAvalign Technologies, Inc.EPY2026-10-16
00724995267391Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267407Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267414Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267421Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267445Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267452Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267469Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267476Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
G141546073500Carnegie Surgical LLCCarnegie Surgical LLCEPY2026-09-30
D955SPCM1Paul BandittTerlain Enterprises, Inc.EPY2026-09-25
00190776432256MillenniumAvalign Technologies, Inc.EPY2026-09-24
00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
04054462156481evonosevonos GmbH & Co. KGEPY2026-08-26
04054462902286evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902293evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902309evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902316evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902330evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902385evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902408evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902415evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902422evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902439evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902446evonosevonos GmbH & Co. KGEPY2026-08-21