THD Procto Software System 800195

GUDID 18033737712341

THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.

THD SPA

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• Primary Device ID: 18033737712341
• NIH Device Record Key: 2435dba4-433e-458b-8a9f-bf5e9c5d5dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Procto Software System
• Version Model Number: THD 4K CAM
• Catalog Number: 800195
• 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: 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

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
• 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
• Phone: +390522634311
• Email: regulatory@thdlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033737712341 [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: 2022-10-17
• Device Publish Date: 2022-10-07

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