ULTRASONIC PROBE

Basic Information

• Brand Name: ULTRASONIC PROBE
• Primary DI: 04953170368554
• Version / Model: UM-2R
• 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: 10
• Public Version Date: 2025-11-24
• Public Version Status: Update
• Public Device Record Key: 39804e96-ac74-41fd-b348-f8dd6ea43a45

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: Ethylene Oxide, High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64359	Flexible endoscopic ultrasound imaging transducer	A flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170368554	GS1

Customer Contacts

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