Freelink™

GUDID 08714729905486

Remote Control Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit

• Primary Device ID: 08714729905486
• NIH Device Record Key: 11f816fc-ad52-4846-a337-bc24a7c84379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freelink™
• Version Model Number: SC-5542-1
• 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: true
• 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	08714729905486 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-21
• Device Publish Date: 2015-09-11

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