UreTron Semi Rigid Sterile Probe 1.5 x 570 mm

Basic Information

• Brand Name: UreTron Semi Rigid Sterile Probe 1.5 x 570 mm
• Primary DI: 00854732006126
• Version / Model: URT-PS-1.5-570S
• Company Name: Ultratellege USA Co., Ltd.
• Labeler DUNS: 118825182
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 590b20a9-c89b-4536-9d79-4b85be0933a5

Device Description

UreTron Semi Rigid Sterile Probe 1.5 x 570 mm

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37139	Ultrasonic lithotripsy system probe, reusable	A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854732006126	GS1

Premarket Submissions

Submission Number	Supplement Number
K160198	000