Freelink™

GUDID 08714729982579

Remote Control

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 08714729982579
• NIH Device Record Key: 9aff4abc-8bcc-4429-bba2-852ee549c0b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freelink™
• Version Model Number: SC-5261
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	08714729982579 [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: 2019-06-03
• Device Publish Date: 2019-05-24

On-Brand Devices [Freelink™]

• 08714729982579: Remote Control
• 08714729995265: Remote Control Kit
• 08714729995180: Remote Control
• 08714729907077: Remote Control Kit
• 08714729897828: Remote Control
• 08714729905486: Remote Control Kit
• 08714729905387: Remote Control