FDA.reportPublic FDA data

OSSEOUS-Ear/Nasal Extractor

Primary DI
08904461031073
Brand
OSSEOUS-Ear/Nasal Extractor
Company
EON MEDITECH PRIVATE LIMITED
Model
E3149
Device description
Nasal Extractor is designed and intended principally for extraction of impacted foreign bodies in the nasal passages. This device may also be used in the external ear canal, based upon clinical judgment.
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904461031073PackageGS15In Commercial Distribution
08904461031080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904461031073089044610310738904461031073
08904461031080089044610310808904461031080

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body inflatable extractorA non-sterile, manual device intended to be inserted into the nasal or ear canal for the extraction of a foreign body/debris. It is a thin tube with a proximal inflation mechanism (e.g., a syringe) and a distal balloon. The distal end is intended to be navigated past the foreign body, after which the balloon is inflated and then pulled back along the canal to dislodge the foreign body. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius0 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
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25