THD REVOLUTION 800139

GUDID 18033737710842

THD Revolution is an electromedical device which, combined with the THD Kits, makes it possible to perform ligation of the haemorrhoidal arteries usin

THD SPA

Invasive vascular ultrasound system Invasive vascular ultrasound system

• Primary Device ID: 18033737710842
• NIH Device Record Key: def41be8-4bf3-4747-9de8-9e4524799deb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD REVOLUTION
• Version Model Number: THD REVOLUTION (US)
• Catalog Number: 800139
• Company DUNS: 338430324
• Company Name: THD SPA
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033737710842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141657

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-14

On-Brand Devices [THD REVOLUTION]

• 18033737710842: THD Revolution is an electromedical device which, combined with the THD Kits, makes it possible
• 38033737710730: THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution dopp