SureTek™

GUDID 08714729820802

Burr Hole Cover Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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