THD Revolution 800070

GUDID 38033737710730

THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD Slide One box contains 10 individually packed disposable doppler probes, which can be immediately be used without preventive cleaning and sterilisation. The box also con-tains 10 absorbable sutures packs (6 sutures each pack) and 10 THD Spon-Anal haemostatic sponges

THD SPA

Invasive vascular ultrasound system probe

• Primary Device ID: 38033737710730
• NIH Device Record Key: c0badd07-fc58-402a-9ce7-3dd35ce31bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Revolution
• Version Model Number: THD Slide One USA
• Catalog Number: 800070
• 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: true
• 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: 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
• 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
• 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	08033737710739 [Primary]
GS1	18033737710736 [Package]; Contains: 08033737710739; Package: [1 Units]; In Commercial Distribution
GS1	28033737710733 [Package]; Contains: 08033737710739; Package: [5 Units]; In Commercial Distribution
GS1	38033737710730 [Package]; Contains: 28033737710733; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090009

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-09-30

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