Sedecal Hercules-65
Sedecal Hercules-65 is a Class I device made by Sedecal., Sa., listed in FDA GUDID since 31 Oct 2016 (UDI-DI 08436046001435), not in commercial distribution (GUDID) 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 | Number08436046001435 | Date31 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 08436046001435
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sedecal
- Generic name
- Diagnostic x-ray system generator, stationary
- Model / reference
- HERCULES-65
- Primary DI / UDI-DI
- 08436046001435
- FDA product code
- IZO
- GMDN term
- Diagnostic x-ray system generator, stationary
- Device class
- Class I
- Regulation number
- 892.1700
- GUDID distribution status
- Not in Commercial Distribution
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