Olympus

Basic Information

• Brand Name: Olympus
• Primary DI: 15019778000879
• Version / Model: Endosonic
• Company Name: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
• Labeler DUNS: 217061423
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: d696f225-ba2f-43e8-886c-0b8c19191c53

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36749	Ultrasonic-cleaning water bath	An electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15019778000879	GS1
Direct Marking	05019778000872	GS1

Premarket Submissions

Submission Number	Supplement Number
K827508	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius