Integra
Integra is a Class II device made by Direx Systems Corp., listed in FDA GUDID since 1 Nov 2016 (UDI-DI 00863499000315), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00863499000315 | Date1 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 00863499000315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Electromechanical lithotripsy system, extracorporeal
- Model / reference
- INTEGRA
- Primary DI / UDI-DI
- 00863499000315
- FDA product code
- LNS
- GMDN term
- Electromechanical lithotripsy system, extracorporeal
- Device class
- Class II
- Regulation number
- 876.5990
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave,Urological).
- Gemini XXP-HP by Dornier MedTech America, Inc.
- ECONOLITH E3000, MODEL 3000 (SW-6) by Medispec, Ltd.
- STORZ MODULITH, MODEL SLX-F2 by Karl Storz Endoscopy-America, Inc.
- EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER by Dornier Medtech Systems
- TWINTRODE ELC 134 ELECTRODE by Healthtronics Surgical Services, Inc.
- EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER by Osmunda Medical Device Consulting Co., Ltd.
- MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI by Karl Storz Lithotripsy-America, Inc.
- Therasonic Lithotripsy Treatment System by Focus Surgery, Inc.
- ULTRASOUND LOCALIZATION SYSTEM ULS 0142 by Hmt High Medical Technologies AG
- LITHOGOLD by Tissue Regeneration Technologies, Inc.