Operon OT 8301065
Operon OT 8301065 is a universal operating table (FDA Class I; FDA product code GDC, Table, Operating-Room, Electrical) made by Berchtold Holding GmbH, listed in FDA GUDID since 27 Aug 2019 (UDI-DI 07613327169997), registry data as of 23 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 | Number07613327169997 | Date27 Aug 2019 | StatusListed |
Official records
- AccessGUDID record 07613327169997
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Operon
- Generic name
- Universal operating table, electrohydraulic
- Model / Ref / Catalog
- OT 8301065
- Primary DI / UDI-DI
- 07613327169997
- FDA product code
- GDC
- GMDN term
- Universal operating table, electrohydraulic
- Device class
- Class I
- Regulation number
- 878.4960
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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Other devices filed under FDA product code GDC (TABLE, OPERATING-ROOM, ELECTRICAL).
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