Olympus

Basic Information

• Brand Name: Olympus
• Primary DI: 04042761034890
• Version / Model: A02959A
• Catalog Number: A02959A
• Company Name: OLYMPUS Winter & Ibe GmbH
• Labeler DUNS: 316957240
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2022-08-18
• Public Version Status: Update
• Public Device Record Key: 7aed4d83-ef1f-4022-936d-b0168b184082
• Distribution End Date: 2018-02-16

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65798	Hard-tissue ultrasonic surgical system holder/tip guide	A hand-held component of an ultrasonic surgical system intended to guide/direct the tip of the system’s holder/tip (not included) which oscillates (vibrates) on hard tissue (e.g., bone) during open or minimally-invasive surgery. It typically has a tubular form with a handle, and may have an elongated distal end to maintain a distance (offset) between its most distal point and the cutting tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04042761034890	GS1

Premarket Submissions

Submission Number	Supplement Number
K951855	000