THD SLIDE ONE

Basic Information

• Brand Name: THD SLIDE ONE
• Primary DI: 18033737710781
• Version / Model: THD OPTI-FIBER (EVO/BT)
• Catalog Number: 880018
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-09
• Public Version: 1
• Public Version Date: 2022-09-19
• Public Version Status: New
• Public Device Record Key: 19537d1e-d24e-41c5-8495-b373d89f057e

Device Description

The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument.

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18033737710781	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090009	000