INSTRUMENT HOLDER (V3) ROSAS00498

GUDID 03760244031969

"INSTRUMENT HOLDER (V3) instrument Rosa One 3.1 (brain application) Mechanical instrument holder for accurate mechanical guidance of neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode) positionned by robot arm in accordance with a pre-operative plan."

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244031969
• NIH Device Record Key: 7e7e3c9a-ecdb-4ad0-bd93-8f63ae6b6895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTRUMENT HOLDER (V3)
• Version Model Number: 174113-00
• Catalog Number: ROSAS00498
• 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	03760244031969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182417

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

[03760244031969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-24
• Device Publish Date: 2020-06-02

On-Brand Devices [INSTRUMENT HOLDER (V3)]

• 03760244033444: "INSTRUMENT HOLDER (V3) instrument Rosa One 3.1 (brain application) Mechanical instrument holder
• 03760244031969: "INSTRUMENT HOLDER (V3) instrument Rosa One 3.1 (brain application) Mechanical instrument holder