FDA.reportPublic FDA data

High-Speed Micro-Motor, small

Primary DI
17630055506525
Brand
High-Speed Micro-Motor, small
Company
Bien-Air Surgery SA
Model
20363033
Catalog number
1700762-001
Published
2023-03-17
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
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HBCMotor, Drill, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBCMotor, Drill, ElectricNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055506525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1763005550652517630055506525

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 non-dental surgical procedures such as drilling or sawing of bones and tough tissues. 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

Regulatory Flags#

DUNS number
481597719
Device count
1
HCT/P
true
Kit
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBC2023-02-22
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBC2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBC2023-02-10
07630055505828BASCH-1 MicromotorBien-Air Surgery SAERL2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBC2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBC2023-02-10