TRIPTER X-1 COMPACT

GUDID 00863499000346

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).

DIREX SYSTEMS CORP.

Spark-gap lithotripsy system

• Primary Device ID: 00863499000346
• NIH Device Record Key: c8c5fb4f-81d4-4244-9522-b4d6f59504f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIPTER X-1 COMPACT
• Version Model Number: COMPACT
• Company DUNS: 837501337
• Company Name: DIREX SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863499000346 [Primary]

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-01

Devices Manufactured by DIREX SYSTEMS CORP.

• 00863499000308 - DUET MAGNA: 2018-03-29 Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The devic
• 00863499000315 - INTEGRA: 2018-03-29 INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.
• 00863499000322 - 3DSCOPE: 2018-03-29 3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-co
• 00863499000339 - COMPACT DUET: 2018-03-29 The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper uretera
• 00863499000346 - TRIPTER X-1 COMPACT: 2018-03-29The 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).
• 00863499000346 - TRIPTER X-1 COMPACT: 2018-03-29 The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The pu