THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

Basic Information

• Brand Name: THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
• Primary DI: 08033737710661
• Version / Model: THD Disposable Light - Scope Truncated Proctostation Kit
• Catalog Number: 800096
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-13
• Public Version: 5
• Public Version Date: 2024-10-28
• Public Version Status: Update
• Public Device Record Key: 05322dd7-3cd8-47e5-b406-2592eba68b58

Device Description

THD Disposable Light-Scope Proctostation Kit is composed by a THD Light-Scope LED anoscope and an adaptor that allow the coupling of the anoscope with a digital camera for inspection and investigation in high resolution of the anal canal. The Light-Scope LED anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field.

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	876.1500	2
FER	Anoscope And Accessories	Gastroenterology, Urology	876.1500	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18033737710668	GS1		10	In Commercial Distribution
Primary	08033737710661	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	90	Millimeter
Outer Diameter	22.1	Millimeter