GUDID 08714729121510

Stylet Kit with Stylet Cap 70cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet Central nervous system electrical stimulation system lead stylet

• Primary Device ID: 08714729121510
• NIH Device Record Key: 497f11f0-db7c-4633-83bd-4c285fac28d5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SC-4385-70
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729121510 [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: 2024-03-19
• Device Publish Date: 2015-11-09

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