OSSEOUS Burs-Course Diamond

Primary DI
08906039315622
Brand
OSSEOUS Burs-Course Diamond
Company
EON MEDITECH PRIVATE LIMITED
Model
EI2145CD
Device description
Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT conditions and anatomies from precise excision in delicate areas to rapid removal of large and bulky lesions.
Published
2024-07-05
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
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
08906039315622PackageGS110In Commercial Distribution
08906039319323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906039315622089060393156228906039315622
08906039319323089060393193238906039319323

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter4.5Millimeter

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#

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08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
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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
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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
08904461001571OSSEOUS Blades-Straight Sinus Blades - N 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