BrightMatter Patient Reference

GUDID 00670082000047

Synaptive Medical Inc

Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00670082000047
• NIH Device Record Key: f66fa2f4-60f9-453e-a6fc-05e5526b3aab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrightMatter Patient Reference
• Version Model Number: SYN-0021
• Company DUNS: 203061833
• Company Name: Synaptive Medical Inc
• Device Count: 1
• DM Exempt: true
• 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	00670082000047 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Synaptive Medical Inc

• 00670082000603 - Modus IR: 2024-04-10 Surgical Exoscope Fluorescence Filter
• 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