THD SLIDE ONE

Basic Information

• Brand Name: THD SLIDE ONE
• Primary DI: 08033737710869
• Version / Model: THD SLIDE
• Catalog Number: 710004
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-30
• Public Version: 1
• Public Version Date: 2025-11-07
• Public Version Status: New
• Public Device Record Key: 52972b13-3c7e-428a-9ea1-50833c7f2c84

Device Description

The THD Slide proctoscope includes a handle and an anatomically shaped sliding part to be inserted transanally in the rectum during the surgical procedure. The handle is shaped so that the tip of the THD Fiber Optic Cable can be inserted. A slot on the sliding part accommodates the Doppler transducer (THD Doppler Probe). The upper portion of the proctoscope includes a window to access the surgical area: this characteristic permits the physician to slide this part during the operation and to position the window correctly for the artery ligation. The movement of the upper part of THD Slide proctoscope allows the physician to obtain a wide surgical window that can be moved in the rectum to facilitate the ligation of the artery and to perform a pexy to reduce the prolapse. The THD Slide device pack includes also a know tightner that facilitate the closure of the knot carried out with the surgical suture. This instrument allows the surgeon to push the knot towards the anal mucosa, avoiding that the surgeon should use his finger to perform this operation. The knot-tightener features a tiny groove for tightening the knot. THD Slide is individually packed and EO sterilized.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
40502	Optical proctoscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033737710869	GS1
Package	18033737710866	GS1	Carton box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K090009	000