ROSA PLANNING STATION ROSAS00349

GUDID 03760244031662

ROSA PLANNING STATION (V3) Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.

MEDTECH

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 03760244031662
• NIH Device Record Key: a819ab9e-ecbc-46d8-8df6-4ae5dbab709f
• Commercial Distribution Discontinuation: 2018-04-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ROSA PLANNING STATION
• Version Model Number: Precision 7510
• Catalog Number: ROSAS00349
• Company DUNS: 264502977
• Company Name: MEDTECH
• 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: false
• Serial Number: true
• 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	03760244031662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151359

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-10-02
• Device Publish Date: 2016-10-09

On-Brand Devices [ROSA PLANNING STATION ]

• 03760244030375: ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, inte
• 03760244031662: ROSA PLANNING STATION (V3) Laptop computer with the following minimal configuration : Windows 7,