ROSA One ROSAS00203

GUDID 03760244030948

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

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244030948
• NIH Device Record Key: 60fd969e-c835-4e31-a7c7-3b8d200595bd
• Commercial Distribution Discontinuation: 2019-09-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ROSA One
• Version Model Number: 3.1.0.5
• Catalog Number: ROSAS00203
• 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: 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	03760244030948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182417

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: 2
• Public Version Date: 2019-09-17
• Device Publish Date: 2019-05-07

Devices Manufactured by MEDTECH

• 00889024671102 - PLANNING STATION - ROSA ONE - USA: 2024-05-28 Planning Station DELL 7520 Qwerty power plug B for Rosa One
• 00887868540028 - ROBOT ARM INTERFACE: 2024-02-28 Robot Arm Interface ROSA One
• 00889024663282 - PLANNING STATION - ROSA ONE - USA: 2024-02-28 Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7
• 03760244031129 - Trnsnsl Endscp Ovoid Ø6.18mm Holder: 2023-11-06 Trnsnsl Endscp Ovoid Ø6.18mm Holder instrument Rosa 3.1 (Brain application) instrument holder for guidance of a Storz sheath 72
• 00887868585951 - ROSA ONE SURGICAL ASSISTANT (US): 2023-10-24 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B
• 03760244034793 - ROSA ONE SURGICAL ASSISTANT (US): 2022-06-28 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B
• 03760244034922 - PLANNING STATION-ROSA ONE- USA: 2022-06-28 planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
• 03760244035127 - PLANNING STATION-ROSA ONE- USA: 2022-06-28 planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5