Radiolucent support arm ROSAS00323

GUDID 03760244034045

RADIOLUCENT SUPPORT ARM instrument Rosa One 3.1 (brain application) Radiolucent support arm for rigid fixation of the robot stand to a neurosurgical head holder (mayfield and PMI DORO) or stereotactic frame (leksell) with adaptors.

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244034045
• NIH Device Record Key: 0f000961-b784-4263-bfd1-b040eab23b18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiolucent support arm
• Version Model Number: 174012-01
• Catalog Number: ROSAS00323
• 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	03760244034045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200511

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-25
• Device Publish Date: 2020-09-17

On-Brand Devices [Radiolucent support arm]

• 03760244031228: RADIOLUCENT SUPPORT ARM instrument Rosa 3.0 instrument Rosa 3.1 Radiolucent support arm for rigi
• 03760244034045: RADIOLUCENT SUPPORT ARM instrument Rosa One 3.1 (brain application) Radiolucent support arm for
• 03760244032133: RADIOLUCENT SUPPORT ARM instrument Rosa One 3.1 (brain application) Radiolucent support arm for