Solo Pace Control System

GUDID 00850056280013

Solo Pace Control System Remote Control Module

SOLO PACE INC.

External pacemaker, epicardial pacing

• Primary Device ID: 00850056280013
• NIH Device Record Key: 7699f486-d273-4d38-9298-a3a8c72d9dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solo Pace Control System
• Version Model Number: SOLORCM
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850056280013 [Primary]
GS1	10850056280010 [Package]; Package: [10 Units]; In Commercial Distribution

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: true

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