FDA.reportPublic FDA data

High-Speed Micro-Motor without cable

Primary DI
07630055507839
Brand
High-Speed Micro-Motor without cable
Company
Bien-Air Surgery SA
Model
20362133
Catalog number
1601125-001
Published
2023-02-22
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
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HBCMotor, Drill, Electric
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBCMotor, Drill, ElectricNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
NLYMicrodebrider, Ent, High Speed, Single Use, ReprocessedEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055507836PackageGS11In Commercial Distribution
07630055507839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550783617630055507836
07630055507839076300555078397630055507839

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motor, electricA hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17630055512502Long Bullnose Blade 22x0.6mm150274015027402023-02-17
17630055512519Long Bullnose Blade 22x0.6mm1502740-0031502740-0032023-02-17
17630055512526Long Bullnose Blade 22x0.6mm1502740-0101502740-0102023-02-17
17630055512533Long Bullnose Blade 27x0.6mm150274115027412023-02-17
17630055512540Long Bullnose Blade 27x0.6mm1502741-0031502741-0032023-02-17
17630055512557Long Bullnose Blade 27x0.6mm1502741-0101502741-0102023-02-17
17630055512564Long Bullnose Blade 32x0.6mm150274215027422023-02-17
17630055512571Long Bullnose Blade 32x0.6mm1502742-0031502742-0032023-02-17
17630055512588Long Bullnose Blade 32x0.6mm1502742-0101502742-0102023-02-17
47630055517706Short Oscillating Blade 6x0.4mm15027241502724-0102026-04-21
47630055517737Short Oscillating Blade 9x0.4mm15027251502725-0102026-04-21
47630055517768Long Oscillating Blade 6x0.4mm15027261502726-0102026-04-21
47630055517799Long Oscillating Blade 9x0.4mm15027271502727-0102026-04-21
47630055519212Short Oscillating Blade 5x0.4mm15027281502728-0102026-04-21
47630055519243Long Oscillating Blade 5x0.4mm15027291502729-0102026-04-21
17630055512236Short Bullnose Blade 22x0.4mm15027312023-02-17
17630055512243Short Bullnose Blade 22x0.4mm1502731-0031502731-0032023-02-17
17630055512250Short Bullnose Blade 22x0.4mm1502731-0101502731-0102023-02-17
17630055512267Short Bullnose Blade 27x0.4mm150273215027322023-02-17
17630055512274Short Bullnose Blade 27x0.4mm1502732-0031502732-0032023-02-17

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Primary DI, Brand, Company table
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04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
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07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
04546540155245NASTRYKER CORPORATIONEQJ2016-09-23
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04546540246356NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
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