FibroScan

GUDID 03662264000065

Pediatric probe

ECHOSENS

Hepatic ultrasound elastography system applicator

• Primary Device ID: 03662264000065
• NIH Device Record Key: f70fce9a-7cec-42f7-af33-62a6090b9561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FibroScan
• Version Model Number: S+
• Company DUNS: 571069108
• Company Name: ECHOSENS
• 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

Customer Support Contacts

• Phone: +33149818929
• Email: service@echosens.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662264000065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150239

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: 2020-03-11
• Device Publish Date: 2016-09-23

On-Brand Devices [FibroScan]

• 03662264001147: FibroScan 430 MINI+
• 03662264001062: FibroScan 530 Compact
• 03662264001048: FibroScan 502 Touch
• 03662264001031: FibroScan 502 Touch
• 03662264000072: XL+
• 03662264000065: Pediatric probe
• 03662264000058: Adult probe
• 03662264001161: FibroScan 630
• 03662264001222: FibroScan 230