ESSENTIO™ MRI SR

GUDID 00802526558948

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526558948
• NIH Device Record Key: 61bead2f-c990-4818-9b3b-119329548d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENTIO™ MRI SR
• Version Model Number: L110
• 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	00802526558948 [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

• 08714729011378 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729011392 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012580 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012603 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012610 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729056645 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729057062 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729080602 - MaxForce TTS: 2024-12-23 High Performance Balloon Dilatation Catheter