UNEX

GUDID 04573349040069

The UNEXEF-38G Ultrasound System is a portable,software controlled ultrasound system used to acquire and display high resolution, real time ultrasound

UNEX CORPORATION

General-purpose ultrasound imaging system

• Primary Device ID: 04573349040069
• NIH Device Record Key: b1df9e47-da8e-4924-8775-8df1ab5f4e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNEX
• Version Model Number: UNEXEF-38G
• Company DUNS: 697250967
• Company Name: UNEX 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: false
• 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	04573349040069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131973

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-29