EXSYS DEXi

GUDID 08800018421505

DRTECH Corporation

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 08800018421505
• NIH Device Record Key: 789afe3f-a240-4894-810f-11f4cacfd879
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXSYS DEXi
• Version Model Number: EXSYS DEXi-D401S-FRM
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018421505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242847

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2025-04-02
• Device Publish Date: 2025-03-25

On-Brand Devices [EXSYS DEXi]

• 08800018425909: EXSYS DEXi-D503T-FRA
• 08800018425800: EXSYS DEXi-D402P-FRA
• 08800018425701: EXSYS DEXi-D401P-FRA
• 08800018425602: EXSYS DEXi-D402S-FRA
• 08800018425503: EXSYS DEXi-D401S-FRA
• 08800018422403: EXSYS DEXi-A503T-FRM
• 08800018422304: EXSYS DEXi-A402P-FRM
• 08800018422205: EXSYS DEXi-A401P-FRM
• 08800018422106: EXSYS DEXi-A402S-FRM
• 08800018422007: EXSYS DEXi-A401S-FRM
• 08800018421901: EXSYS DEXi-D503T-FRM
• 08800018421802: EXSYS DEXi-D402P-FRM
• 08800018421703: EXSYS DEXi-D401P-FRM
• 08800018421604: EXSYS DEXi-D402S-FRM
• 08800018421505: EXSYS DEXi-D401S-FRM