EM Probe Bracket Kit, C1-6, Single XR90-PBRK-C16-01

GUDID 10860006066342

Single ultrasound probe bracket for use with GE C1-6-D transducers.

Mediview Xr, Inc.

Ultrasound imaging system tracking positioner, single-use

• Primary Device ID: 10860006066342
• NIH Device Record Key: a95aff2a-56dc-49fb-af0c-918cbeb1fbad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM Probe Bracket Kit, C1-6, Single
• Version Model Number: SPEC-0551
• Catalog Number: XR90-PBRK-C16-01
• 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	00860006066345 [Primary]
GS1	10860006066342 [Package]; Contains: 00860006066345; Package: Case [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: 2025-01-10
• Device Publish Date: 2025-01-02

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