ROSA PLANNING STATION ROSAS00369

GUDID 03760244030375

ROSA PLANNING STATION 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

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244030375
• NIH Device Record Key: 12af3634-cf45-4096-9141-72c4c1c10c7b
• Commercial Distribution Discontinuation: 2019-09-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ROSA PLANNING STATION
• Version Model Number: DELL 7520
• Catalog Number: ROSAS00369
• 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	03760244030375 [Primary]

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: 3
• Public Version Date: 2019-09-19
• Device Publish Date: 2018-04-25

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,