CoverEdge™ MRI

GUDID 08714729995821

Surgical Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead Implantable electrical stimulation system intraoperative test lead

• Primary Device ID: 08714729995821
• NIH Device Record Key: 8ed29d1d-7429-4301-9b23-7bd0002e8762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoverEdge™ MRI
• Version Model Number: SC-8436-70
• 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: 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

• 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
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter
• Length: 70 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729995821 [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: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [CoverEdge™ MRI]

• 08714729995821: Surgical Lead Kit
• 08714729995814: Surgical Lead Kit