Sirona RX92864-000
by Datrix LLC
Sirona RX92864-000 is a Class II device made by Datrix LLC, listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00851074007101), 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 | Number00851074007101 | Date19 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00851074007101
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sirona
- Generic name
- Telemetric electrocardiographic ambulatory recorder
- Model / reference
- RX92864-000
- Primary DI / UDI-DI
- 00851074007101
- FDA product code
- MWJ
- GMDN term
- Telemetric electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
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