FDA.reportPublic FDA data

Bur OSSEOSTAP Diam Ø1.2 mm St

Primary DI
27630055504702
Brand
Bur OSSEOSTAP Diam Ø1.2 mm St
Company
Bien-Air Surgery SA
Model
1501428
Catalog number
1501428-001
Published
2020-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
EQJBur, Ear, Nose And Throat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27630055504702PackageGS11In Commercial Distribution
17630055504705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763005550470227630055504702
1763005550470517630055504705

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

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08904461030892OSSEOUS- Shaver Blade Tube EON MEDITECH PRIVATE LIMITEDEQJ2026-03-13
17630055519419Bur PM2-70 80K steel Ø1.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519525Bur PM2-70 80K diam EC Ø4.0x80 StBien-Air Surgery SAEQJ2026-02-16
27630055519539Bur PM2-70 80K steel Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519549Bur PM2-70 80K steel Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519556Bur PM2-70 80K diam Ø1.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519563Bur PM2-70 80K diam Ø1.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519570Bur PM2-70 80K diam EC Ø5.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519587Bur PM2-70 80K diamC Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
27630055519591Bur PM2-70 80K steel Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519600Bur PM2-70 80K steel Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519617Bur PM2-70 80K diamC Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519624Bur PM2-70 80K diamC Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519655Bur PM2-70 80K diam Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519662Bur PM2-70 80K diam Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
27630055519676Bur PM2-70 80K steel Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519686Bur PM2-70 80K steel Ø3x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519716Bur PM2-70 80K diamC Ø5.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519723Bur PM2-70 80K diamC Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519730Bur PM2-70 80K diam Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519747Bur PM2-70 80K diam Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519754Bur PM2-70 80K diam Ø3.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519761Bur PM2-70 80K diam Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519778Bur PM2-70 80K FC Ø0.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519785Bur PM2-70 80K FC Ø1.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519792Bur PM2-70 80K FC Ø1.5x80 StBien-Air Surgery SAEQJ2026-02-16