TELIGEN

Basic Information

• Brand Name: TELIGEN
• Primary DI: 10705034555164
• Version / Model: 286003310
• Catalog Number: 286003310
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: 9434e1ab-28b0-4e66-a0c5-c74d47d37703

Device Description

TELIGEN PEDAL LENS CLEANING

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63197	Endoscopic irrigation/aspiration foot-pedal	A manual, foot-operated device designed to be used in conjunction with a dedicated irrigation tubing set and a disposable syringe to facilitate displacement of the syringe plunger for irrigation of an endoscopic site. It is intended to house the syringe which is intended to be connected to a tubing set with an appropriate inflow/outflow valve, whereby lifting the foot-pedal fills the syringe from an irrigation solution source, and pressing the foot-pedal displaces fluid from the syringe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705034555164	GS1

Customer Contacts

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