Duns Number:837501337
Device Description: The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, ren 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).
Catalog Number
-
Brand Name
TRIPTER X-1 COMPACT
Version/Model Number
COMPACT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LNS
Product Code Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |