FDA.reportPublic FDA data

Bur PM2-95 80K steel Ø5.0mm sterile

Primary DI
J00711004510011
Brand
Bur PM2-95 80K steel Ø5.0mm sterile
Company
Bien-Air Surgery SA
Model
1100451
Catalog number
1100451-001
Published
2019-01-08
Public version status
Update
Distribution status
Not 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
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00711004510011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metal/carbide ENT bur, single-useA small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481597719
Device count
1
Lot or batch
true
Expiration date on label
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
00816589021615Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
00816589021622Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505545S120 ShaverBien-Air Surgery SAEQJ2023-02-09
07630055505576S120 CableBien-Air Surgery SAEQJ2023-02-09
07630055505637OSSEOSTAP + CableBien-Air Surgery SAEQJ2023-02-09
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505675PM2-A70Bien-Air Surgery SAEQJ2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAEQJ2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAEQJ2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAEQJ2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAEQJ2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAEQJ2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09