3D X-RAY PATTERN ROSAS00499

GUDID 03760244033383

3D X-RAY PATTERN instrument Rosa one 3.1 (spine application) Calibrated device to register intraoperative 3D exams 174021-02&03

MEDTECH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244033383
• NIH Device Record Key: 97eddb86-6891-4a49-a778-9c01f37d169f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D X-RAY PATTERN
• Version Model Number: 174021
• Catalog Number: ROSAS00499
• Company DUNS: 264502977
• Company Name: MEDTECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	03760244033383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192173

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

[03760244033383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

On-Brand Devices [3D X-RAY PATTERN]

• 03760244030443: 3D X-RAY PATTERN instrument Rosa one (spine application) Calibrated device to register intraoper
• 03760244031785: 3D X-RAY PATTERN instrument Rosa one 3.1 (spine application) Calibrated device to register intra
• 03760244033383: 3D X-RAY PATTERN instrument Rosa one 3.1 (spine application) Calibrated device to register intra