ROSA® Brain ROSAS00303

GUDID 03760244031051

Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B

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: 03760244031051
• NIH Device Record Key: 79a2ebd7-26b8-4466-a7fb-245308c4ac74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROSA® Brain
• Version Model Number: 3.0.0
• Catalog Number: ROSAS00303
• 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: true
• 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	03760244031051 [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: 4
• Public Version Date: 2020-10-02
• Device Publish Date: 2016-10-09

On-Brand Devices [ROSA® Brain]

• 03760244031754: Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , touch screen, s
• 03760244031051: Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , touch screen, s