TRIPTER X-1 COMPACT

Basic Information

• Brand Name: TRIPTER X-1 COMPACT
• Primary DI: 00863499000346
• Version / Model: COMPACT
• Company Name: DIREX SYSTEMS CORP.
• Labeler DUNS: 837501337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c8c5fb4f-81d4-4244-9522-b4d6f59504f7

Device Description

The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The purpose of the Shock Wave Generator is to convert the electric energy stored in a capacitor into mechanical energy. By generating high-energy sparks under water, shock waves are produced. The reflectors then focus these waves to converge at the common therapeutic focal point (F2).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological	Gastroenterology, Urology	876.5990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18417	Spark-gap lithotripsy system	An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a spark-gap generator. The generator delivers shock waves when an electrical discharge between two electrodes submerged in water or in electrolytes causes explosive vaporization; the shock wave expands from the gap between the electrodes and is focused at the stone by an ellipsoidal reflector. This system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863499000346	GS1