Evry

GUDID 10670082000495

Synaptive Medical Inc

Extremity MRI system, superconducting magnet

• Primary Device ID: 10670082000495
• NIH Device Record Key: eb592cd3-730a-4002-97d9-12b8011dc185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evry
• Version Model Number: SYN-0777
• Company DUNS: 203061833
• Company Name: Synaptive Medical Inc
• 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: 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	00670082000450 [Primary]
GS1	10670082000495 [Package]; Contains: 00670082000450; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200327

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2023-10-24
• Device Publish Date: 2020-06-05

Devices Manufactured by Synaptive Medical Inc

• 00670082000252 - Multi-Tool Calibration Device: 2025-06-23
• 00670082000269 - Short Pointer: 2025-06-23
• 00670082000351 - Sterilizable Storage Tray: 2025-06-23
• 00670082000467 - Modus V: 2025-06-23 Robotic Digital Microscope
• 00670082000474 - Modus V: 2025-06-23 Robotic Digital Microscope
• 00670082000504 - Modus Nav Software: 2025-06-23
• 00670082000528 - Modus Nav Operator Cart: 2025-06-23
• 00670082000535 - Long Pointer: 2025-06-23