THD N-ano anoscope

Basic Information

• Brand Name: THD N-ano anoscope
• Primary DI: 08033737710715
• Version / Model: Anoscope N-Ano MAXI Truncated
• Catalog Number: 800165
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-12
• Public Version: 3
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 90947f27-2e3d-4459-beb5-115148dcd01a

Device Description

The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal. The THD N-ano 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. The THD N-ano anoscope is ready-to-use and does not need for other tools.

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
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	28033737710719	GS1	Cartoon Box	50	In Commercial Distribution
Primary	08033737710715	GS1
Package	18033737710712	GS1	Cartoon Box	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133687	000

Device Sizes

Type	Value	Unit	Text
Length	110	Millimeter
Outer Diameter	26	Millimeter