AccessGUDID - DEVICE: TRIPTER X-1 COMPACT (00863499000346)

GUDID

Device Identifier (DI) Information

Brand Name: TRIPTER X-1 COMPACT
Version or Model: COMPACT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DIREX SYSTEMS CORP.

Primary DI Number: 00863499000346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837501337 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8c5fb4f-81d4-4244-9522-b4d6f59504f7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 01, 2016