EM Probe Bracket Kit, C1-5, Single

GUDID 00850044606023

MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.

Mediview Xr, Inc.

Ultrasound imaging system tracking positioner, single-use

• Primary Device ID: 00850044606023
• NIH Device Record Key: 7c169302-bc26-43e4-a819-f479dc1b2096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM Probe Bracket Kit, C1-5, Single
• Version Model Number: SPEC-0310
• 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: true
• 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	00850044606023 [Primary]
GS1	10850044606020 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223125

FDA Product Code

• 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

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• 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: 2023-10-31MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.
• 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.