SureTek™

GUDID 08714729820802

Burr Hole Cover Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system

• Primary Device ID: 08714729820802
• NIH Device Record Key: 1f8b81c5-01ba-4118-ad7a-f69f4fac97bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureTek™
• Version Model Number: DB-4600-C
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729820802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• PJS: Stimulator, electrical, implanted, for essential tremor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-29
• Device Publish Date: 2017-12-15

On-Brand Devices [SureTek™]

• 08714729820819: Burr Hole Cover Spares Kit
• 08714729820802: Burr Hole Cover Kit