Bionic Navigator™

GUDID 08714729991328

2.04 Installer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729991328
• NIH Device Record Key: 2a11e161-3501-43bb-aeeb-70572e442635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionic Navigator™
• Version Model Number: DB-7101-204-W10
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• 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	08714729991328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• NHL: Stimulator, electrical, implanted, for parkinsonian symptoms

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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [Bionic Navigator™]

• 08714729991380: 1.2 Installer
• 08714729991328: 2.04 Installer
• 08714729935094: 3.1 Installer
• 08714729935087: 1.2 Installer