Registration Marker Kit, Sterile, Single

GUDID 10850044606013

MediView single sterile Registration Marker kit for use with XR90.

Mediview Xr, Inc.

Electromagnetic device tracking system spatial marker

• Primary Device ID: 10850044606013
• NIH Device Record Key: 3d166d99-3d39-48ce-98bc-c40588c01369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Registration Marker Kit, Sterile, Single
• Version Model Number: SPEC-0303
• 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: true
• 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	00850044606016 [Primary]
GS1	10850044606013 [Package]; Contains: 00850044606016; 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: true
• Device Is Sterile: true

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

[10850044606013]

Ethylene Oxide

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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