ESSENTIO™ MRI DR

GUDID 00802526558962

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526558962
• NIH Device Record Key: 7c83e17a-bb3f-428d-8cd2-a0c9dcc18430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENTIO™ MRI DR
• Version Model Number: L111
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC 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: false
• Serial Number: true
• 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	00802526558962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150012

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (non-CRT)

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: 2019-11-04
• Device Publish Date: 2016-05-10

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 08714729269915 - Electrophysiology Cable: 2025-01-15 Sterile Cable
• 08714729877868 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877875 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877882 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877899 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877905 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877912 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter