Kit, Aurora FG Mounting Brackets, RT

GUDID 00850044606047

Electromagnetic Field Generator Mounting Brackets (Right) for use with the MediView XR90 system.

Mediview Xr, Inc.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 00850044606047
• NIH Device Record Key: 27b12b3b-728a-436b-bcc6-d8c39a7556df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kit, Aurora FG Mounting Brackets, RT
• Version Model Number: XR90-BRK-FG-RT
• Company DUNS: 117407269
• Company Name: Mediview Xr, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044606047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223125

FDA Product Code

• BWN: Table And Attachments, Operating-Room
• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

Devices Manufactured by Mediview Xr, Inc.

• 10860006066342 - EM Probe Bracket Kit, C1-6, Single: 2025-01-10 Single ultrasound probe bracket for use with GE C1-6-D transducers.
• 00860006066369 - XR90 System, LOGIQ: 2025-01-10
• 00860006066376 - XR90 System, LOGIQ, Single Headset: 2025-01-10
• 00860006066383 - XR90 System, LOGIQ, Upgrade Kit: 2025-01-10
• 00850044606061 - OmnifyXR: 2023-11-09 The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a co
• 00850044606009 - Triangle Template Kit: 2023-11-01 MediView Triangle Template Kit for use with the XR90 system.
• 10850044606013 - Registration Marker Kit, Sterile, Single: 2023-10-31 MediView single sterile Registration Marker kit for use with XR90.
• 00850044606023 - EM Probe Bracket Kit, C1-5, Single: 2023-10-31 MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.