ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Basic Information

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Primary DI: 04953170310386
• Version / Model: OLYMPUS LTF-S190-10
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 4959e1b1-c520-485d-ba6f-f08c1d1f808f

Device Description

LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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", "High-level Disinfectant", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
NWB	Endoscope, accessories, narrow band spectrum	Gastroenterology, Urology	876.1500	2
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4760	2
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43053	Rigid video laparoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170310386	GS1

Customer Contacts

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