FDA.reportPublic FDA data

HS Diam. Burr, Ø1.8x150, 80k

Primary DI
27630055507376
Brand
HS Diam. Burr, Ø1.8x150, 80k
Company
Bien-Air Surgery SA
Model
360218 L
Catalog number
1100596-001
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBCMotor, Drill, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBCMotor, Drill, ElectricNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27630055507376PackageGS11In Commercial Distribution
17630055507379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763005550737627630055507376
1763005550737917630055507379

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use 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
17630055519419Bur PM2-70 80K steel Ø1.5 St11013692026-02-16
17630055519525Bur PM2-70 80K diam EC Ø4.0x80 St11014342026-02-16
27630055519539Bur PM2-70 80K steel Ø2.0 St11013702026-02-16
17630055519549Bur PM2-70 80K steel Ø2.0x80 St11013972026-02-16
17630055519556Bur PM2-70 80K diam Ø1.5 St11013752026-02-16
17630055519563Bur PM2-70 80K diam Ø1.5x80 St11014012026-02-16
17630055519570Bur PM2-70 80K diam EC Ø5.0x80 St11014202026-02-16
17630055519587Bur PM2-70 80K diamC Ø2.0 St11013812026-02-16
27630055519591Bur PM2-70 80K steel Ø2.5 St11013712026-02-16
17630055519600Bur PM2-70 80K steel Ø2.5x80 St11013982026-02-16
17630055519617Bur PM2-70 80K diamC Ø2.0x80 St11014242026-02-16
17630055519624Bur PM2-70 80K diamC Ø2.5x80 St11014252026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 St11014172026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 St11014262026-02-16
17630055519655Bur PM2-70 80K diam Ø2.0 St11013762026-02-16
17630055519662Bur PM2-70 80K diam Ø2.0x80 St11014022026-02-16
27630055519676Bur PM2-70 80K steel Ø3.0 St11013722026-02-16
17630055519686Bur PM2-70 80K steel Ø3x80 St11013992026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 St11013822026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 St11014272026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722333ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722357MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722425MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-21
08809260473669SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473676SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473713SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473942SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473980SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474017SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474697SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474727SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474987SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474994SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260475038SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
00721902573613MIDAS REXMEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-03-27
07630055508072PM2-S MISBien-Air Surgery SAHBC2025-03-21
17630055508093PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
17630055512601PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBC2025-03-20
04560264529243Primado2NAKANISHI INC.HBC2025-01-22
04560264529250Primado2NAKANISHI INC.HBC2025-01-22
17630055513820Bur Cranial Spiral 25mm StBien-Air Surgery SAHBC2024-12-04
17630055515664Bur PM2-150 80K Diam Ø4.0 StBien-Air Surgery SAHBC2024-12-04
17630055515671Bur PM2-150 80K Diam Ø3.1 StBien-Air Surgery SAHBC2024-12-04
17630055515688Bur PM2-150 80K Diam Ø1.8 StBien-Air Surgery SAHBC2024-12-04
17630055515695Bur PM2-150 80K Diam Ø1.0 StBien-Air Surgery SAHBC2024-12-04
17630055516135Bur PM2-125 80K Diam Ø4.0 StBien-Air Surgery SAHBC2024-12-04
17630055516791Bur PM2-95 80K Diam EC Ø4.7 StBien-Air Surgery SAHBC2024-12-04
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBC2024-04-27