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

• 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