Infinion™ CX

GUDID 08714729861645

70cm 16 Contact Trial Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation system intraoperative test lead

• Primary Device ID: 08714729861645
• NIH Device Record Key: b2afaace-b4a2-4657-867c-1afbf3314062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinion™ CX
• Version Model Number: SC-2317-70E
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729861645 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-19
• Device Publish Date: 2015-12-14

On-Brand Devices [Infinion™ CX]

• 08714729861645: 70cm 16 Contact Trial Lead Kit
• 08714729861638: 70cm 16 Contact Lead Kit
• 08714729861621: 50cm 16 Contact Trial Lead Kit
• 08714729861614: 50cm 16 Contact Lead Kit