PHASOR

Basic Information

• Brand Name: PHASOR
• Primary DI: B775PH53070DTPHKA1S0
• Version / Model: PH-530-70-DT + PH-K-A1S
• Catalog Number: PH-530-70-DT + PH-K-A1S
• Company Name: PHASOR HEALTH LLC
• Labeler DUNS: 111926675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 2
• Public Version Date: 2022-03-07
• Public Version Status: Update
• Public Device Record Key: 7fed6d55-05d4-4a61-b76b-1d3dcee5f6c8
• Distribution End Date: 2121-06-07

Device Description

Phasor Drill, 5.30-mm diameter, with Drill stop extension, Tapered, plus Kit (version A1) with stapler

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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
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
35884	Skin stapler/staple, non-bioabsorbable	A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B775PH53070DTPHKA1S0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K161704	000