Infinion™ Pro M365SC2318500

GUDID 00191506018726

Lead Kit 16 Contact 50cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

• Primary Device ID: 00191506018726
• NIH Device Record Key: 117c1214-1d00-40f6-beda-829eb62d3564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinion™ Pro
• Version Model Number: SC-2318-50
• Catalog Number: M365SC2318500
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506018726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [Infinion™ Pro]

• 00191506018733: Lead Kit 16 Contact 70cm
• 00191506018726: Lead Kit 16 Contact 50cm