PHASOR

Basic Information

• Brand Name: PHASOR
• Primary DI: B775635CK0
• Version / Model: 6.35CK
• Company Name: PHASOR HEALTH LLC
• Labeler DUNS: 111926675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-19
• Public Version: 2
• Public Version Date: 2026-03-30
• Public Version Status: Update
• Public Device Record Key: 043cc6d8-519b-4fb3-8e98-412b5b46e9e7
• Distribution End Date: 2126-01-20

Device Description

Phasor Cranial Access Kit, with Phasor Drill quick-connect, 6.35-mm Bit, with Phasor Legacy manual drill and Phasor electric Drill, with Kit

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	882.4300	2
OJG	Neurological Tray	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44064	Neurosurgical procedure kit, medicated	A collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.	No	Active
46281	Manual cranial rotary handpiece, single-use	A manually-powered, hand-held, surgical device 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)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B775635CK0	HIBCC