PHASOR
- Primary DI
- B775EZFIDUCIALS0
- Brand
- PHASOR
- Company
- PHASOR HEALTH LLC
- Model
- EZ-FIDUCIALS
- Catalog number
- EZ-FIDUCIALS
- Device description
- Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, allsingle-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 shouldexclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and withno 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 solelytightening or loosening the provided screws exclusively, not intended for use with any other screws).
- Published
- 2025-08-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| HAW | Neurological Stereotaxic Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K250505 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B775EZFIDUCIALS0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Electromagnetic device tracking system spatial marker | A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time images [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US)]. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| (832) 982-1234 | info@phasorhealth.com |
Regulatory Flags#
- DUNS number
- 111926675
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B775140L0 | PHASOR | 14.0L | 2026-04-04 | |
| B775140S0 | PHASOR | 14.0S | 2026-04-04 | |
| B775110L0 | PHASOR | 11.0L | 2026-03-27 | |
| B775110S0 | PHASOR | 11.0S | 2026-03-27 | |
| B7752IN105CK0 | PHASOR | 2-IN-1-05CK | 2026-03-27 | |
| B7752IN125LKX0 | PHASOR | 2-IN-1-25LKX | 2026-03-27 | |
| B7752IN1260 | PHASOR | 2-IN-1-26 | 2026-03-28 | |
| B7752IN145CK0 | PHASOR | 2-IN-1-45CK | 2026-03-28 | |
| B7753IN1245K0 | PHASOR | 3-IN-1-245K | 2026-03-27 | |
| B7753IN1256CK0 | PHASOR | 3-IN-1-256CK | 2026-03-28 | |
| B7753IN145RK0 | PHASOR | 3-IN-1-45RK | 2026-03-28 | |
| B7754IN12456K0 | PHASOR | 4-IN-1-2456K | 2026-03-28 | |
| B775840L0 | PHASOR | 8.40L | 2026-03-27 | |
| B775840S0 | PHASOR | 8.40S | 2026-03-27 | |
| B775635CK0 | PHASOR | 6.35CK | 2026-01-19 | |
| B7752IN125LK0 | PHASOR | 2-IN-1-25LK | 2025-11-24 | |
| B7752IN126LK0 | PHASOR | 2-IN-1-26LK | 2025-11-24 | |
| B7752IN145LK0 | PHASOR | 2-IN-1-45LK | 2025-11-24 | |
| B7753IN1246LK0 | PHASOR | 3-IN-1-246LK | 2025-11-24 | |
| B7753IN1256LK0 | PHASOR | 3-IN-1-256LK | 2025-11-24 |
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| 00860012056828 | Zeta Navigation System | Zeta Surgical Inc. | HAW | 2026-06-02 |
| 08720892330826 | Ball Joint Guide Array (BJGA)-Navigation Set | Bayer Medical Care B.V. | HAW | 2026-04-24 |
| 08720892330833 | Ball Joint Guide Array (BJGA)-Guide Set | Bayer Medical Care B.V. | HAW | 2026-04-24 |
| 07340201501887 | Leksell Vantage Stereotactic System | Elekta Solutions AB | HAW | 2025-03-31 |
| 10381780542278 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2024-06-28 |
| 10381780542285 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2024-06-28 |
| 10381780542292 | Integra® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2024-06-03 |
| G076A012354A1 | Localite TMS Navigator TS | LOCALITE GmbH | HAW | 2023-07-05 |
| G076A012355A1 | Localite TMS Navigator TS | LOCALITE GmbH | HAW | 2023-07-05 |
| 07613327499711 | N/A | Stryker Leibinger GmbH & Co. KG | HAW | 2023-03-23 |
| 07613327500516 | N/A | Stryker Leibinger GmbH & Co. KG | HAW | 2022-07-22 |
| 07613327500561 | N/A | Stryker Leibinger GmbH & Co. KG | HAW | 2022-07-22 |
| 07613327500578 | N/A | Stryker Leibinger GmbH & Co. KG | HAW | 2022-07-22 |
| 07613327503265 | N/A | Stryker Leibinger GmbH & Co. KG | HAW | 2022-07-22 |
| 10603295522850 | VELYS | DEPUY (IRELAND) | HAW | 2021-07-30 |
| 07613327413076 | n/a | Stryker Leibinger GmbH & Co. KG | HAW | 2018-08-08 |
| 07613327413090 | n/a | Stryker Leibinger GmbH & Co. KG | HAW | 2018-08-08 |
| 07613327413205 | n/a | Stryker Leibinger GmbH & Co. KG | HAW | 2018-08-08 |
| 10603295493624 | SIGMA | DEPUY ORTHOPAEDICS, INC. | HAW | 2018-04-19 |
| 10650551098277 | PMT CORPORATION - STEREOTACTIC | PMT CORPORATION | HAW | 2018-01-28 |
| 10381780167334 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252252 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252351 | Integra® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252368 | Integra® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252375 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252382 | Integra® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252399 | Integra® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252405 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |
| 10381780252412 | CRW® | INTEGRA LIFESCIENCES CORPORATION | HAW | 2017-04-14 |