Modus Nav Software SYN-0867

GUDID 00670082000627

Synaptive Medical Inc

Neurological stereotactic surgery system

• Primary Device ID: 00670082000627
• NIH Device Record Key: 7dd58900-f859-4285-9f44-849aee28d156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modus Nav Software
• Version Model Number: 2.2
• Catalog Number: SYN-0867
• 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: 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	00670082000627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183325

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2025-06-23
• Device Publish Date: 2025-01-17

On-Brand Devices [Modus Nav Software]

• 00670082000627: 2.2
• 00670082000504: 2.1