FDA.reportPublic FDA data

OSSEOUS Blades-Straight Sinus Blades - N Type

Primary DI
08904461001571
Brand
OSSEOUS Blades-Straight Sinus Blades - N Type
Company
EON MEDITECH PRIVATE LIMITED
Model
EI2212
Device description
ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system to remove tissue, bone, or other obstructions in the sinuses.
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EQJBur, Ear, Nose And Throat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904461001564PackageGS11In Commercial Distribution
08904461001571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904461001564089044610015648904461001564
08904461001571089044610015718904461001571

GMDN Terms#

Term, Definition table
TermDefinition
Nasal biopsy curetteA sterile, hand-held, manual instrument designed to remove nasal mucosal cells, intended for laboratory examination and/or testing, usually by gently scraping the inferior surface of the inferior turbinate. The instrument typically has a spoon-like working end and a flexible handle; it is typically made of plastic. It is commonly used to collect samples for testing to determine the respiratory epithelial response to air pollutants and for assessing drug effects [e.g., in cystic fibrosis (CF) patients]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 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
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
08904461028783OSSEOUS- Shaver Blade Tube EON MEDITECH PRIVATE LIMITEDEQJ2026-03-13
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAEQJ2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAEQJ2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAEQJ2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAEQJ2025-03-20
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
08904428723409OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723416OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723423OSSEOUS Blade-Straight Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723430OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723447OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723454OSSEOUS Blade-Curved Sinus Blades - TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723461OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723478OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723485OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723492OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723515OSSEOUS Blade - Inferior turbinate - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723539OSSEOUS Blade-Straight Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723546OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723553OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723560OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723577OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000505OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000529OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000956OSSEOUS Burs-Course DiamondEON MEDITECH PRIVATE LIMITEDEQJ2024-07-05
08904461000888OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000895OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000901OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000918OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04