REMI Robotic Navigation System

GUDID 00850026574715

Aesculap Instrument Case

Fusion Robotics, LLC

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system

• Primary Device ID: 00850026574715
• NIH Device Record Key: 6e4d33e4-c9dc-4b32-8887-78e773696cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMI Robotic Navigation System
• Version Model Number: 1102
• Company DUNS: 117229400
• Company Name: Fusion Robotics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00850026574715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202184

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

[00850026574715]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-01
• Device Publish Date: 2022-06-23

On-Brand Devices [REMI Robotic Navigation System]

• 00850026574715: Aesculap Instrument Case
• 00850026574579: 100mm x 6mm PSIS Pin
• 00850026574555: 150mm x 6mm PSIS Pin
• 00850026574722: REMI 8.5 mm Cann. Dual Lead Tap
• 00850026574708: REMI 7.5 mm Cann. Dual Lead Tap
• 00850026574692: REMI 6.5 mm Cann. Dual Lead Tap
• 00850026574685: REMI 5.5 mm Cann. Dual Lead Tap
• 00850026574678: REMI 5.0 mm Cann. Dual Lead Tap
• 00850026574661: REMI 4.5 mm Cann. Dual Lead Tap