FDA.reportPublic FDA data

S120 Shaver

Primary DI
07630055505545
Brand
S120 Shaver
Company
Bien-Air Surgery SA
Model
1600614
Catalog number
1600614-001
Published
2023-02-09
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
EQJBur, Ear, Nose And Throat
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
NLYMicrodebrider, Ent, High Speed, Single Use, ReprocessedEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055505542PackageGS11In Commercial Distribution
J00716006140011PreviousHIBCC0
07630055505545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550554217630055505542
07630055505545076300555055457630055505545

GMDN Terms#

Term, Definition table
TermDefinition
ENT shaver system handpieceA handle with attached cutting blade that is a component of a line-powered ENT shaver system and 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 is typically connected to and regulated through a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and may be used in combination with appropriate endoscopic devices. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
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
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
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505040PMRM 1122 70mmBien-Air Surgery SAERL2023-02-09
07630055505095PMAM 1221 70 mmBien-Air Surgery SAERL2023-02-09
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
07613327504019NASTRYKER CORPORATIONERL2021-07-08
07630055502230Bur PM2-70 50K Diam Ø0.6Bien-Air Surgery SAEQJ2020-05-28
07630055502247Bur PM2-70 50K Diam Ø0.8Bien-Air Surgery SAEQJ2020-05-28
07630055502254Bur PM2-70 50K Diam Ø1.0Bien-Air Surgery SAEQJ2020-05-28
07630055502261Bur PM2-70 50K Diam Ø1.4Bien-Air Surgery SAEQJ2020-05-28
07630055502278Bur PM2-70 50K Diam Ø1.8Bien-Air Surgery SAEQJ2020-05-28
07630055502285Bur PM2-70 50K Diam Ø2.3Bien-Air Surgery SAEQJ2020-05-28
07630055502292Bur PM2-70 50K Diam Ø2.7Bien-Air Surgery SAEQJ2020-05-28
07630055502308Bur PM2-70 50K Diam Ø3.1Bien-Air Surgery SAEQJ2020-05-28
07630055502315Bur PM2-70 50K Diam Ø3.5Bien-Air Surgery SAEQJ2020-05-28
07630055502322Bur PM2-70 50K Diam Ø4.0Bien-Air Surgery SAEQJ2020-05-28
07630055502339Bur PM2-70 50K Diam Ø4.5Bien-Air Surgery SAEQJ2020-05-28
07630055502346Bur PM2-70 50K Diam Ø5.0Bien-Air Surgery SAEQJ2020-05-28
07630055502353Bur PM2-70 50K Diam Ø6.0Bien-Air Surgery SAEQJ2020-05-28
07630055502360Bur PM2-70 50K Diam Ø7.0Bien-Air Surgery SAEQJ2020-05-28
07630055502377Bur PM2-70 50K Carb Ø0.5Bien-Air Surgery SAEQJ2020-05-28