EXPD 4357

GUDID 08800018407905

DRTECH Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08800018407905
• NIH Device Record Key: d87192b9-23a1-4abf-85e4-b45eb08d0f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPD 4357
• Version Model Number: EXPD 4357
• 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	08800018407905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231959

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2023-09-12
• Device Publish Date: 2023-09-04

Devices Manufactured by DRTECH Corporation

• 08800018408506 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408605 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408704 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408803 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018421505 - EXSYS DEXi: 2025-04-02
• 08800018421604 - EXSYS DEXi: 2025-04-02
• 08800018421703 - EXSYS DEXi: 2025-04-02
• 08800018421802 - EXSYS DEXi: 2025-04-02