Compact Duet
Compact Duet is a Class II device made by Direx Systems Corp., listed in FDA GUDID since 2 Nov 2016 (UDI-DI 00863499000339), 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 | Number00863499000339 | Date2 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 00863499000339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Spark-gap lithotripsy system
- Model / reference
- COMPACT DUET
- Primary DI / UDI-DI
- 00863499000339
- FDA product code
- LNS
- GMDN term
- Spark-gap lithotripsy system
- Device class
- Class II
- Regulation number
- 876.5990
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave,Urological).
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