FDA.reportPublic FDA data

NANO Micromotor + Cable

Primary DI
J00717005010011
Brand
NANO Micromotor + Cable
Company
Bien-Air Surgery SA
Model
1700501
Catalog number
1700501-001
Published
2019-01-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HBCMotor, Drill, Electric
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBCMotor, Drill, ElectricNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00717005010011PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
Kit
true
Lot or batch
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
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
08809260473430TRAUSSaeshin Precision Co., Ltd.HBC2026-05-20
08809260475489TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475496TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475502TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475427TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475434TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475441TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475465TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475472TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBC2023-02-22