Infinion™ Pro M365SC2318700

GUDID 00191506018733

Lead Kit 16 Contact 70cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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

• Primary Device ID: 00191506018733
• NIH Device Record Key: 765ae0cf-a11b-43d5-8911-c947fc150df2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinion™ Pro
• Version Model Number: SC-2318-70
• Catalog Number: M365SC2318700
• 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: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506018733 [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: 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