EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG

GUDID 08800018408704

DRTECH Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08800018408704
• NIH Device Record Key: 7261ab6f-510a-456b-a68d-105560617ec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG
• Version Model Number: EXPD 114P
• 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	08800018408704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242770

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: 2025-04-04
• Device Publish Date: 2025-03-27

On-Brand Devices [EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG]

• 08800018408803: EXPD 114PG
• 08800018408704: EXPD 114P
• 08800018408605: EXPD 114G
• 08800018408506: EXPD 114