FDA.reportPublic FDA data

Set OSSEOUNO + S120

Primary DI
J00717003000011
Brand
Set OSSEOUNO + S120
Company
Bien-Air Surgery SA
Model
1700300
Catalog number
1700300-001
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00717003000011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT shaver systemAn assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.

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
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