BrightMatter Guide Software SYN-0027

GUDID 00670082000375

Synaptive Medical Inc

Neurological stereotactic surgery system

• Primary Device ID: 00670082000375
• NIH Device Record Key: 6869c9c6-fc45-496c-88f0-123e82782b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrightMatter Guide Software
• Version Model Number: 1.5
• Catalog Number: SYN-0027
• 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	00670082000375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153281

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-28

On-Brand Devices [BrightMatter Guide Software]

• 00670082000375: 1.5
• 00670082000191: 1.4
• 00670082000078: 1.3