Bionic Navigator™ 3D

GUDID 00191506007546

4.1 Installer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation device management software

• Primary Device ID: 00191506007546
• NIH Device Record Key: 18a898a9-db1b-4197-91b7-ca74d5b1948d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionic Navigator™ 3D
• Version Model Number: SC-7101-410
• 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: 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	00191506007546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief

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: 2021-08-23
• Device Publish Date: 2021-08-15

On-Brand Devices [Bionic Navigator™ 3D]

• 08714729990376: 2.20 Installer
• 08714729991366: 2.20 Installer
• 08714729991373: 2.10 Installer
• 08714729995203: 4.0 Installer
• 00191506007546: 4.1 Installer