DEVICE: TRIPTER X-1 COMPACT (00863499000346)
Device Identifier (DI) Information
TRIPTER X-1 COMPACT
COMPACT
In Commercial Distribution
DIREX SYSTEMS CORP.
COMPACT
In Commercial Distribution
DIREX SYSTEMS CORP.
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
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
c8c5fb4f-81d4-4244-9522-b4d6f59504f7
March 29, 2018
2
November 01, 2016
March 29, 2018
2
November 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined