EVIS EXERA PLEURAVIDEOSCOPE

Basic Information

• Brand Name: EVIS EXERA PLEURAVIDEOSCOPE
• Primary DI: 04953170340284
• Version / Model: OLYMPUS LTF TYPE 160
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 7
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 594169eb-1839-4ce4-9c1e-e86427d49f76
• Distribution End Date: 2024-01-12

Device Description

LTF-160, PLEUROSCOPE 7.0MM DIA 2.8MM CH

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: Yes
• 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: ["High-level Disinfectant", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64431	Rigid video thoracoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the thoracic cavity. It is inserted through a dedicated incision made in the chest wall during thoracoscopy. 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	04953170340284	GS1

Customer Contacts

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