SoloPace EPG

GUDID 00850056280020

SOLO PACE INC.

External pacemaker, epicardial pacing

• Primary Device ID: 00850056280020
• NIH Device Record Key: 2698f31d-144c-42da-8299-7c4124eaa1b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoloPace EPG
• Version Model Number: SOLOEPG1
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850056280020 [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: 2026-02-10
• Device Publish Date: 2026-02-02

Devices Manufactured by SOLO PACE INC.

• 00850056280020 - SoloPace EPG: 2026-02-10
• 00850056280020 - SoloPace EPG: 2026-02-10
• 00850056280013 - Solo Pace Control System: 2025-01-31 Solo Pace Control System Remote Control Module
• 00850056280037 - Solo Pace Control System: 2025-01-31 Solo Pace Control External Pulse Generator