GUDID 08714729960720

Enhanced Steering Kit with Stylet Cap 74cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Central nervous system electrical stimulation system lead stylet

• Primary Device ID: 08714729960720
• NIH Device Record Key: c5587e55-54e3-4cef-8582-5021cbb36213
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SC-4395-74
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729960720 [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: 2024-08-21
• Device Publish Date: 2017-08-15

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729897804 - NA: 2024-08-21 Installer for BN3.1
• 08714729897811 - NA: 2024-08-21 Clinician Programmer
• 08714729897835 - Precision Novi™: 2024-08-21 Implantable Pulse Generator Kit
• 08714729897873 - NA: 2024-08-21 Clinican Programmer (Refurbished)
• 08714729904816 - Avista™ MRI: 2024-08-21 56cm 8 Contact Lead Kit
• 08714729904823 - Avista™ MRI: 2024-08-21 74cm 8 Contact Lead Kit
• 08714729905387 - Freelink™: 2024-08-21 Remote Control
• 08714729905486 - Freelink™: 2024-08-21 Remote Control Kit