FDA.report

Bur PM2-70 80K Mstick Ø1.8 St

Primary DI
27630055504153
Brand
Bur PM2-70 80K Mstick Ø1.8 St
Company
Bien-Air Surgery SA
Model
1100460
Catalog number
1100460-001
Published
2023-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications

CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
27630055504153PackageGS11In Commercial Distribution
J00711004600011PreviousHIBCC0
17630055504156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2763005550415327630055504153
1763005550415617630055504156

GMDN Terms

TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
04589551366583Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366590Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366606Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366613Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
B775635CK0PHASORPHASOR HEALTH LLCHBE2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCHBE2025-11-24
00763000679682POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-28
00763000683511POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-27
00763000722388MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722319ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-17
00763000892722Midas Rex ClearviewMEDTRONIC XOMED, INC.HBE2025-06-23
06429811532069Surgify Halo | 4.0 mm | ShortSurgify Medical OyHBE2025-06-18
06429811532076Surgify Halo | 4.0 mm | ExtendableSurgify Medical OyHBE2025-06-18
06429811532083Surgify Halo | 4.0 mm | LongSurgify Medical OyHBE2025-06-18
15059358034986ZethonZETHON LIMITEDHBE2025-05-14
05059358036457ZethonZETHON LIMITEDHBE2025-05-14
15059358036478ZethonZETHON LIMITEDHBE2025-05-14