FDA.reportPublic FDA data

OSSEOUS-Ear/Nasal Extractor

Primary DI
08904461031080
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
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

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
08904428799749OSSEOUS- Adhesion Remover PadEA910632026-03-13

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Primary DI, Brand, Company table
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09348811172143INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-03-18
08904461055697OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00190776416218MillenniumAvalign Technologies, Inc.LRC2026-02-12
00190776416232MillenniumAvalign Technologies, Inc.LRC2026-02-12