THD SLIDE ONE

Basic Information

Brand Name: THD SLIDE ONE
Primary DI: 08051887047918
Version / Model: THD ANOLIFT US
Catalog Number: 800330
Company Name: THD SPA
Labeler DUNS: 338430324
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-04-03
Public Version: 1
Public Version Date: 2025-04-11
Public Version Status: New
Public Device Record Key: bd966bef-ca86-4b08-b9ac-db498b1dfa95

Device Description

THD Slide is specifically designed to be immediately used with the 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 ANOLIFT US kit is a disposable kit containing the following medical devices, each one individually pack withing each kit carton box: - THD Slide - THD Doppler Probe - Sutures (both traditional for ligation and barbed sutures for mucopexy)

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	892.1540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44914	Optical anoscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.	No	Active
61226	Invasive vascular ultrasound system probe	A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status
Package	18051887047915	GS1	Carton box	1	In Commercial Distribution
Primary	08051887047918	GS1
Package	28051887047912	GS1	Carton box	5	In Commercial Distribution
Package	38051887047919	GS1	Carton box	2	In Commercial Distribution

Customer Contacts

Phone: +390522634311
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K090009	000