FDA.reportPublic FDA data

BASCH Micromotor

Primary DI
17630055505023
Brand
BASCH Micromotor
Company
Bien-Air Surgery SA
Model
1600076
Catalog number
1600076-001
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792159000FISCH DRILL SYSTEMJedmed Instrument Co.1979-11-27ERL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055505023PackageGS11In Commercial Distribution
J00716000760011PreviousHIBCC0
07630055505026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550502317630055505023
07630055505026076300555050267630055505026

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37630055512506Long Bullnose Blade 22x0.6mm15027401502740-0032026-08-25
37630055512537Long Bullnose Blade 27x0.6mm15027411502741-0032026-08-25
37630055512568Long Bullnose Blade 32x0.6mm15027421502742-0032026-08-25
47630055512503Long Bullnose Blade 22x0.6mm15027401502740-0102026-08-25
47630055512534Long Bullnose Blade 27x0.6mm15027411502741-0102026-08-25
47630055512565Long Bullnose Blade 32x0.6mm15027421502742-0102026-08-25
27630055512509Long Bullnose Blade 22x0.6mm15027401502740-0012026-08-25
27630055512530Long Bullnose Blade 27x0.6mm15027411502741-0012026-08-25
27630055512561Long Bullnose Blade 32x0.6mm15027421502742-0012026-08-25
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

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
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
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
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAERL2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507853Cable for HS-Micro-Motor,largeBien-Air Surgery SAERL2023-02-22
07630055507860Perforator MotorBien-Air Surgery SAERL2023-02-22
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
07630055505828BASCH-1 MicromotorBien-Air Surgery SAERL2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAERL2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAERL2023-02-10