REMI Robotic Navigation System

GUDID 00850026574579

100mm x 6mm PSIS Pin

Fusion Robotics, LLC

Robotic surgical navigation system

• Primary Device ID: 00850026574579
• NIH Device Record Key: 5dd28d36-2250-4ba8-9de1-05a6f352a802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMI Robotic Navigation System
• Version Model Number: 6026
• 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: true
• 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	00850026574579 [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

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

Moist Heat or Steam Sterilization

[00850026574579]

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