Phasor Drill

Basic Information

• Brand Name: Phasor Drill
• Primary DI: M710008102804
• Version / Model: 1
• Company Name: BIOTEX, INC.
• Labeler DUNS: 969792050
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-16
• Public Version: 6
• Public Version Date: 2021-01-04
• Public Version Status: Update
• Public Device Record Key: a5d14be6-3ccb-4011-965d-92dac828c101
• Distribution End Date: 2019-08-30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	882.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46275	Craniotomy power tool system, battery-powered, single-use	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M710008102804	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]