phasorhealth.comEVAC-MRI
Phasor Health, LLC
PHASOR HEALTH, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016577622 | 3016577622 | PHASOR HEALTH, LLC | 1 | N | 2026-01-01 | 8944 Kirby Drive Houston TX US 77054 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B775EZFIDUCIALS0 | PHASOR - Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton): (1) Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver); (2) Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws; (3) EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws). | (832) 982-1234 | info@phasorhealth.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 238332 | 1940992286 | K252696 | LEGACY | HBG | 2025-11-21 |
| 238332 | 1125236562 | K252514 | EVAC-MRI | JXG | 2025-11-05 |
| 238332 | 1605162471 | K252060 | GREEN | HBE | 2025-10-31 |
| 238332 | 1507472259 | K250505 | EZ-FIDUCIALS | HAW | 2025-07-09 |
| 238332 | 1390519557 | K243205 | EVAC | JXG | 2025-06-03 |
| 238332 | 1901785196 | K161704 | Phasor Drill | HBE | 2016-12-01 |
| 238332 | 1545842141 |
Product Codes Associated With Registrations#
PMN#
GREEN
Phasor Health, LLC
EZ-FIDUCIALS
Phasor Health, LLC
EVAC
Phasor Health, LLC
GUDID#
PHASOR - Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton): (1) Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver); (2) Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws; (3) EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws).
2025-08-21
PHASOR - Phasor Drill, 14.0 mm diameter, long length
2026-04-04
PHASOR - Phasor Drill, 14.0 mm diameter, short
2026-04-04
PHASOR - Phasor Drill, 11.0 mm diameter, long
2026-03-27
PHASOR - Phasor Drill, 11.0 mm diameter, short length
2026-03-27
PHASOR - Phasor Cranial Access Kit, includes both Electric and Manual Drivers, quick-connect, with bit diameters 4.80-mm and 5.30-mm diameter, with drug-containing Kit
2026-03-27
PHASOR - Phasor Cranial Access Kit, with Drill quick-connect 2-IN-1 with 2.70-mm, 5.30-mm diameter bits, with Kit (drug-free)
2026-03-27
PHASOR - Phasor Drill, quick-connect, with Electric Driver, with bit diameters 2.70-mm, 6.35-mm
2026-03-28
PHASOR - Phasor Cranial Access Kit, 2-IN-1, quick-connect, with Electric and Manual Drivers BOTH, with bit diameters 4.50-mm and 5.30-mm, with Kit
2026-03-28
PHASOR - Phasor Cranial Access Kit, 3-IN-1-, with Electric Driver, quick-connect, with bit diameters 2.70-mm, 4.50-mm, 5.30-mm, with Kit (drug-containing)
2026-03-27
PHASOR - Phasor Cranial Access Kit, 3-IN-1, quick-connect, with Electric and Manual Drivers BOTH with bit diameters 2.70-mm, 5.30-mm, 6.35-mm, with Kit
2026-03-28
PHASOR - Phasor Cranial Access Kit, 3-IN-1, quick-connect, with Electric Driver, bit diameters 4.50-mm, 5.30-mm, 6.50-mm, with Kit
2026-03-28
PHASOR - Phasor Cranial Access Kit, 4-IN-1 quick-connect, with Electric Driver, bit sizes 2.70-mm, 4.50-mm, 5.30-mm, 6.35-mm, with Kit
2026-03-28
PHASOR - Phasor Drill, 8.40-mm, long
2026-03-27
PHASOR - Phasor Drill, 8.40-mm diameter, short
2026-03-27
PHASOR - Phasor Cranial Access Kit, with Phasor Drill quick-connect, 6.35-mm Bit, with Phasor Legacy manual drill and Phasor electric Drill, with Kit
2026-01-19
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone,with interchangeable quick-connect, 2 bits (diameters 2.70-mm, 5.30-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 2 bits (diameters 2.70-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone,with interchangeable quick-connect, 2 bits (diameters 4.50-mm, 5.30-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 3 bits (diameters 2.70-mm, 4.50-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 3 bits (diameters 2.70-mm, 5.30-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 4 bits (diameters 2.70-mm, 4.50-mm, 5.30-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 5 bits (diameters 2.70-mm, 4.50-mm, 5.30-mm, 5.80-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 2 bits (diameters 2.70-mm, 6.35-mm) with Kit.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 3 bits (diameters 2.70-mm, 4.50-mm, 6.35-mm) with Kit.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 3 bits (diameters 2.70-mm, 5.30-mm, 6.35-mm) with Kit.
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 4 bits (diameters 2.70-mm, 4.50-mm, 5.30-mm, 6.35-mm) with Kit.
2025-11-24
PHASOR - Phasor EVAC-MRI is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Phasor EVAC-MRI system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Phasor EVAC–MRI system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma. (The device is MRI-conditional for the titanium bolt.)
2025-11-24
PHASOR - "Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone. (This item contains the single-use sterilized drill bit assembly, whereby GRE.DBA.XXX indicates ""XXX"" as the drill bit designation.)"
2025-11-24
PHASOR - Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone. (This item refers to the re-sterilizable drill driver.)
2025-11-24
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 2 bits (diameters 2.70-mm, 5.30-mm) with Kit.
2025-11-23
PHASOR - The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 2 bits (diameters 4.50-mm, 5.30-mm) with Kit.
2025-11-23
PHASOR - Phasor Drill, 2-IN-1, with Drill Stops, Kit (optional stapler) -- featuring sizes 2.70mm diameter and 5.30-mm diameter, with Kit
2025-10-22
PHASOR - Phasor Drill, 2-IN-1, with Drill Stops
2025-10-21
PHASOR - Phasor EVAC subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.
2025-06-04
PHASOR - Phasor Drill, 5-IN-1, with Drill Stops
2024-12-15
PHASOR - Phasor Drill, 5-IN-1, with Drill Stops, Kit (optional stapler)
2024-12-15
PHASOR - Phasor Drill 2.10-mm diameter, ~210-mm length
2024-11-08
PHASOR - Phasor Drill 4.50-mm diameter,~210-mm length
2024-09-05
PHASOR - Phasor Drill 2.40-mm diameter, length ~210-mm
2023-02-20