FDA.reportPublic FDA data

Bur PM2-70 50K Diam C Ø7.0

Primary DI
07630055503923
Brand
Bur PM2-70 50K Diam C Ø7.0
Company
Bien-Air Surgery SA
Model
1100437
Catalog number
1100437-001
Published
2020-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
17630055503920PackageGS11In Commercial Distribution
07630055503923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550392017630055503920
07630055503923076300555039237630055503923

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into an appropriate handpiece that provides the rotation allowing the user to incise or remove bone in the ear, nose, or throat area during an ear/nose/throat (ENT) procedure. It can be used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

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