TOUCH PANEL FOR ENDOALPHA

Basic Information

• Brand Name: TOUCH PANEL FOR ENDOALPHA
• Primary DI: 04953170291470
• Version / Model: MAJ-1828
• Catalog Number: N3626130
• 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: 8
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: ea3ca1a8-c8bd-4de0-af03-a78643b83ac5

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: 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
ODA	endoscopic central control unit	Gastroenterology, Urology	876.1500	2
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64496	Touchscreen	An electrically-powered visual display unit (VDU) designed as an output device for displaying data (e.g., patient images, videos) and as an input device to enable interactive manipulation of the data by the operator through touches to the display screen. It is intended to be connected to a computer or a medical device (i.e., the screen has no computing capabilities); it may be used to control a medical device (e.g., operating room lights) depending on parent device software. It is typically a portable or mounted liquid crystal display (LCD) or light-emitting diode (LED) unit, and may include an antimicrobial material to prevent cross-contamination in a medical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170291470	GS1

Customer Contacts

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