Accordion CoAx Stone Control Device

Basic Information

• Brand Name: Accordion CoAx Stone Control Device
• Primary DI: 00857252004009
• Version / Model: PA1305-01-15
• Catalog Number: PA1305-01-15
• Company Name: T H S INTERNATIONAL, INC.
• Labeler DUNS: 101084796
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 5
• Public Version Date: 2020-01-27
• Public Version Status: Update
• Public Device Record Key: 257afcef-86ba-4218-825f-e25ed928d969
• Distribution End Date: 2020-01-24

Device Description

Accordion CoAx Stone Control Device

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: No
• 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
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	876.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60482	Ureteropelvic stone filtering catheter	A flexible tubular device with a non-detachable expandable filter at the distal end intended to be temporarily introduced, via the ureter or percutaneously, into the urinary tract to prevent migration/allow filtration of stone fragments during a lithotripsy procedure. It may also be used for the injection of a contrast medium for fluoroscopic visualization (i.e., retrograde pyelogram), guidance of other devices and/or drainage of fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857252004009	GS1

Customer Contacts

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