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Phasor

FDA UDI

Class II (US FDA UDI)

by Phasor Health, LLC

Identity

Trade Name
PHASOR FDA UDI
Generic Name
Electromagnetic device tracking system spatial marker FDA UDI
Device Name
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). FDA UDI
Model / Reference
EZ-FIDUCIALS FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
EZ-FIDUCIALS FDA UDI
Primary DI / UDI-DI
B775EZFIDUCIALS0 FDA UDI
510(k) Number
K250505 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Electromagnetic device tracking system spatial marker FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic device tracking system spatial marker

Phasor by Phasor Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic device tracking system spatial marker.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phasor Health, LLC

Sources (1)

  • FDA UDI de1fc0b9-534b-492d-82e5-2940968f7583 37 fields · synced Jun 8, 2026