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

• 00670082000603 - Modus IR: 2024-04-10 Surgical Exoscope Fluorescence Filter
• 10670082000495 - Evry: 2023-10-24
• 10670082000495 - Evry: 2023-10-24
• 00670082000511 - Modus Plan: 2023-10-18
• 00670082000566 - Modus X: 2023-03-14 Robotic Exoscope
• 00670082000573 - Modus X: 2023-03-14 Robotic Exoscope
• 00670082000580 - Modus Blue: 2023-03-14 Robotic Exoscope Fluorescence Filter
• 00670082000085 - BrightMatter Plan: 2019-08-16
• 00670082000160 - BrightMatter Plan: 2019-08-16