Home GUDID 10850044606013 Registration Marker Kit, Sterile, Single
Primary DI 10850044606013
Brand Registration Marker Kit, Sterile, Single
Company Mediview Xr, Inc.
Model SPEC-0303
Device description MediView single sterile Registration Marker kit for use with XR90.
Published 2023-10-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true 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 10850044606013 Package GS1 8 In Commercial Distribution 00850044606016 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 10850044606013 10850044606013 00850044606016 00850044606016 850044606016 0850044606016
GMDN Terms# Term, Definition table 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 table Method Ethylene Oxide
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 true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850044606078 XR90 EM Field Generator XR90-GEN-TB 2026-06-17 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 00860006066307 MediScout system MS-100-1001 2021-04-20
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