FDA.reportPublic FDA data

Bur OSSEOSTAP Carb Ø0.6 mm St

Primary DI
17630055504552
Brand
Bur OSSEOSTAP Carb Ø0.6 mm St
Company
Bien-Air Surgery SA
Model
1501223
Catalog number
1501223-001
Published
2020-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
27630055504559PackageGS11In Commercial Distribution
17630055504552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763005550455927630055504559
1763005550455217630055504552

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear drill bitA cylindrical shaft of metal with a small cutting head (e.g., twisted or helicoidal) which when rotated will bore into the tissues of the middle ear to excavate, perforate, or excise tissue (e.g., ossicles, cartilage) during a middle ear (endaural) surgical procedure. This device is typically mounted into a powered surgical drill system handpiece that provides rotation. It is available in various cutting head sizes/shapes. This is a reusable device.

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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