EXPD-N series

GUDID 08800018430200

DRTECH Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08800018430200
• NIH Device Record Key: 99954959-aaed-401b-8130-44b3f1554d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPD-N series
• Version Model Number: EXPD 4343U1
• 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	08800018430200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243443

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: 2025-06-23
• Device Publish Date: 2025-06-13

On-Brand Devices [EXPD-N series]

• 08800018430903: EXPD 3643NP
• 08800018430804: EXPD 3643NU
• 08800018430705: EXPD 3643U1
• 08800018430606: EXPD 3643N
• 08800018430507: EXPD 3643N1
• 08800018430408: EXPD 4343NP
• 08800018430309: EXPD 4343NU
• 08800018430200: EXPD 4343U1
• 08800018430101: EXPD 4343N
• 08800018430002: EXPD 4343N1