Solo Pace Control System

GUDID 00850056280037

Solo Pace Control External Pulse Generator

SOLO PACE INC.

External pacemaker, epicardial pacing

• Primary Device ID: 00850056280037
• NIH Device Record Key: 31b2f232-bfac-478d-8b79-a84f55a29a46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solo Pace Control System
• Version Model Number: SOLOEPG1L
• Company DUNS: 138344845
• Company Name: SOLO PACE INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00850056280037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241781

FDA Product Code

• DTE: Pulse-Generator, Pacemaker, External

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-31
• Device Publish Date: 2025-01-23

On-Brand Devices [Solo Pace Control System]

• 00850056280037: Solo Pace Control External Pulse Generator
• 00850056280013: Solo Pace Control System Remote Control Module