THD Procto Software System 800198

GUDID 18033737712389

THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes: - THD Procto Software - proctology integrated software - Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle

THD SPA

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• Primary Device ID: 18033737712389
• NIH Device Record Key: 35f8b0b2-d315-4e17-b5e2-97b5a135812b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Procto Software System
• Version Model Number: THD Proctostation
• Catalog Number: 800198
• 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: 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: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033737712389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211623

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [THD Procto Software System]

• 18033737712389: THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal
• 08033737713037: The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic f
• 58051887042642: THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathol
• 18033737712341: THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution usi
• 68051887043325: THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal S
• 68051887043318: THD DIGITAL MOBILE ECOGRAPHY is an integrated mobile proctological platform for the Colo-Rectal
• 68051887043301: THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal
• 68051887043295: THD DIGITAL MOBILE is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ P