FDA.reportPublic FDA data

Perfo OSSEOSTAP Ø0.35 mm St

Primary DI
17630055505955
Brand
Perfo OSSEOSTAP Ø0.35 mm St
Company
Bien-Air Surgery SA
Model
1501240
Catalog number
1501240-001
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
27630055505952PackageGS11In Commercial Distribution
17630055505955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763005550595227630055505952
1763005550595517630055505955

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SANLY2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SANLY2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SANLY2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SANLY2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAEQJ2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055506542HS Diam. Burr, Ø0.6x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506559HS Diam. Burr, Ø0.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506566HS Diam. Burr, Ø1.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506573HS Diam. Burr, Ø1.4x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506580HS Diam. Burr, Ø1.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506597HS Diam. Burr, Ø2.3x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506603HS Diam. Burr, Ø2.7x70, 50kBien-Air Surgery SAEQJ2023-02-22