FDA.reportPublic FDA data

Phasor Drill

Primary DI
M710008102804
Brand
Phasor Drill
Company
BIOTEX, INC.
Model
1
Published
2017-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M710008102804PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniotomy power tool system, battery-powered, single-useA dedicated battery-powered assembly of devices intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)]; it may also be used for the removal of a bone flap for brain surgery. It typically consists of a handpiece containing a motor (engine), a battery-pack, an attachment with a clutch system that disengages the cutting tool when the inner table has been penetrated preventing injury to the brain, and an exchangeable rotating cutting tool (e.g., a cranial drill bit, bur, trephine or perforator). This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
713-741-0111xxx@xx.xx

Regulatory Flags#

DUNS number
969792050
Device count
1
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
M710TCW51000Bayou™ troCarWash System Disposable KitTCW-5-1002025-10-10
M710TCW101200Bayou™ troCarWash System Disposable KitTCW-10-1202024-01-31
M71004614002Slide Bite Fork046-1400046-14002025-02-28
M710NDK2Safe-Cam Tablet and Accessories033-5000SC-NDK2018-07-25
M710SCC0Safe-Cam Connecting Cable Assembly033-6500SC-C2018-07-25
M710SCM0Safe-Cam Display Monitor Assembly033-6501SC-M2018-07-25
M710SCMR0Safe-Cam Display Monitor Charger033-6000-003SC-MR2018-07-25
M710SCVS0Safe-Cam Sterile Video Stylet033-1000SC-VS2018-07-25
M710TCWC0Bayou™ troCarWash System ControllerTCW-C2024-01-22
M710WW1D0Wire Watch™WW-1D2024-07-03
M710ERGUIDE10050OcciGuide048-1001ER GUIDE 10052021-02-25
M710ERGUIDE10100OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE1010OcciGuideER GUIDE 1010048-10002020-02-20
M71003810000Bayou™ troCarWash System Disposable Kit038-10002023-08-04
M71003850000Bayou™ troCarWash System Controller038-50002023-08-04
M710WW12K0Wire Watch™WW-12K2023-07-31
M71002110010Wire Watch™021-10012023-02-09
M71004615000The Slide®046-15002023-05-19
M71004610000The Slide®046-10002021-09-01
M710ERGUIDE10102OcciGuide048-1000ER GUIDE 10102021-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBE2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBE2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBE2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SAHBE2023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SAHBE2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAHBE2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09