THD SensyProbe 750032

GUDID 08033737712306

THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided with a male luer lock that allows the connection to the THD SensyProbe inflation line.

THD SPA

Gastrointestinal motility manometric catheter, non-electronic

• Primary Device ID: 08033737712306
• NIH Device Record Key: 2feed46c-9440-4cc6-84e6-3564ed60ffe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD SensyProbe
• Version Model Number: THD SensyProbe Accessory
• Catalog Number: 750032
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033737712306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180135

FDA Product Code

• KLA: Monitor, Esophageal Motility, And Tube

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: 2022-08-05
• Device Publish Date: 2018-03-20

On-Brand Devices [THD SensyProbe]

• 08033737712306: THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided wit
• 08033737712290: THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform