CoverEdge™ X MRI

GUDID 08714729995838

Surgical Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation system intraoperative test lead

• Primary Device ID: 08714729995838
• NIH Device Record Key: 2d3956c6-b683-46da-a964-720a8f399760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoverEdge™ X MRI
• Version Model Number: SC-8452-50
• 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: 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
• 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
• 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	08714729995838 [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™ X MRI]

• 08714729995845: Surgical Lead Kit
• 08714729995838: Surgical Lead Kit