EXTRON 5

GUDID 08800018420805

DRTECH Corporation

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 08800018420805
• NIH Device Record Key: 16922c0f-5352-482a-a75b-d7fc3a6e6ccc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTRON 5
• Version Model Number: EXTRON 5
• Company DUNS: 689842626
• Company Name: DRTECH Corporation
• 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: true
• 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	08800018420805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230871

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2023-09-01
• Device Publish Date: 2023-08-24

Devices Manufactured by DRTECH Corporation

• 08800018422601 - EXTRON 3: 2025-06-25
• 08800018430002 - EXPD-N series: 2025-06-23
• 08800018430101 - EXPD-N series: 2025-06-23
• 08800018430200 - EXPD-N series: 2025-06-23
• 08800018430309 - EXPD-N series: 2025-06-23
• 08800018430408 - EXPD-N series: 2025-06-23
• 08800018430507 - EXPD-N series: 2025-06-23
• 08800018430606 - EXPD-N series: 2025-06-23