Home GUDID 00850044606078 XR90 EM Field Generator
Primary DI 00850044606078
Brand XR90 EM Field Generator
Company Mediview Xr, Inc.
Model XR90-GEN-TB
Published 2026-06-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LLZ System, Image Processing, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLZ System, Image Processing, Radiological Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850044606078 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850044606078 00850044606078 850044606078 0850044606078
GMDN Terms# Term, Definition table Term Definition Electromagnetic surgical navigation/tracking system An assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).
Regulatory Flags# DUNS number 117407269 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850044606085 XR90 EM Field Generator XR90-GEN-PV 2026-06-17 00850044606092 XR90 EM Field Generator XR90-GEN-PX 2026-06-17 00850044606108 XR90 EM Field Generator XR90-GEN-WF 2026-06-17 00850044606016 Registration Marker Kit, Sterile, Single SPEC-0303 2023-10-23 00860006066369 XR90 System, LOGIQ XR90-SYS-LOGIQ 2025-01-02 00860006066376 XR90 System, LOGIQ, Single Headset XR90-LQ-HMD01 2025-01-02 00860006066383 XR90 System, LOGIQ, Upgrade Kit XR90-LQ-UPGRADE 2025-01-02 00850044606061 OmnifyXR OXR-SYS 2023-11-01 00850044606054 XR90 XR90-SYS 2023-10-23 00850044606030 Kit, Aurora FG Mounting Brackets, LT XR90-BRK-FG-LT 2023-10-23 00850044606047 Kit, Aurora FG Mounting Brackets, RT XR90-BRK-FG-RT 2023-10-23 00860006066345 EM Probe Bracket Kit, C1-6, Single SPEC-0551 XR90-PBRK-C16-01 2025-01-02 10860006066342 EM Probe Bracket Kit, C1-6, Single SPEC-0551 XR90-PBRK-C16-01 2025-01-02 00850044606023 EM Probe Bracket Kit, C1-5, Single SPEC-0310 XR90-PBRK-C15-01 2023-10-23 00850044606009 Triangle Template Kit XR90-CT-KIT 2023-10-24 10850044606013 Registration Marker Kit, Sterile, Single SPEC-0303 2023-10-23 00860006066307 MediScout system MS-100-1001 2021-04-20
Other Devices Sharing Product Codes#