CoverEdge™ X 32

GUDID 08714729832683

50cm 4x8 Surgical Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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

• Primary Device ID: 08714729832683
• NIH Device Record Key: 584e7750-5f45-43a8-a9ba-cf6c6b41da69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoverEdge™ X 32
• Version Model Number: SC-8352-50
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729832683 [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: 2024-08-20
• Device Publish Date: 2015-12-14

On-Brand Devices [CoverEdge™ X 32]

• 08714729832690: 70cm 4x8 Surgical Lead Kit
• 08714729832683: 50cm 4x8 Surgical Lead Kit