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: 08033737710623
• Version / Model: THD Light - Scope LED Large Rectoscope with inflation bulb Sterile
• Catalog Number: 800118
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: aaa8efa7-facc-4f02-a93f-133f972c0cfc

Device Description

The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The Light-Score LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED rectoscope is ready-to-use and it also available with an inflating included

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
FER	Anoscope And Accessories	Gastroenterology, Urology	876.1500	2
GCP	Endoscope, Ac-Powered 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	18033737710620	GS1		10	In Commercial Distribution
Primary	08033737710623	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121135	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	20	Millimeter
Length	240	Millimeter