GUDID 00802526579448

Lead Stylets, Long Tapered, Soft

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead stylet

• Primary Device ID: 00802526579448
• NIH Device Record Key: 0a4a89ab-92f3-4fe0-9300-5d72143dada2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5012
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC 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

• 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	00802526579448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150012

FDA Product Code

• NVN: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-10

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• 08714729877882 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
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• 08714729877905 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877912 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter