FDA.reportPublic FDA data

Set OSSEODOC + BASCH-1

Primary DI
17630055506228
Brand
Set OSSEODOC + BASCH-1
Company
Bien-Air Surgery SA
Model
1700541
Catalog number
1700541-001
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
J00717005410011PreviousHIBCC0
17630055506228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1763005550622817630055506228

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
Kit
true
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
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
17630055512281Short Bullnose Blade 27x0.4mm1502732-0101502732-0102023-02-17
17630055512298Short Bullnose Blade 32x0.4mm150273315027332023-02-17
17630055512304Short Bullnose Blade 32x0.4mm1502733-0031502733-0032023-02-17
17630055512311Short Bullnose Blade 32x0.4mm1502733-0101502733-0102023-02-17
17630055512328Short Bullnose Blade 22x0.6mm150273415027342023-02-17
17630055512335Short Bullnose Blade 22x0.6mm1502734-0031502734-0032023-02-17
17630055512342Short Bullnose Blade 22x0.6mm1502734-0101502734-0102023-02-17
17630055512359Short Bullnose Blade 27x0.6mm150273515027352023-02-17
17630055512366Short Bullnose Blade 27x0.6mm1502735-0031502735-0032023-02-17
17630055512373Short Bullnose Blade 27x0.6mm1502735-0101502735-0102023-02-17
17630055512380Short Bullnose Blade 32x0.6mm150273615027362023-02-17
17630055512403Short Bullnose Blade 32x0.6mm1502736-0101502736-0102023-02-17
17630055512410Long Bullnose Blade 22x0.4mm150273715027372023-02-17
17630055512427Long Bullnose Blade 22x0.4mm1502737-0031502737-0032023-02-17
17630055512434Long Bullnose Blade 22x0.4mm1502737-0101502737-0102023-02-17

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
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