AMSCO 400 Steam Sterilizer
by Steris Mexico, S. de R.L. de C.V. 234 variants
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00724995368562 | Date8 Oct 2026 | StatusListed |
Recalls
-
- Terminated Z-0586-2020
The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
-
- Terminated Z-1561-2015
STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Amsco
- Generic Name
- Steam sterilizer
- Model / Ref / Catalog
- AMSCO 400 Steam Sterilizer, SR4414324021
- Primary DI / UDI-DI
- 00724995368562
- 510(k) Number
- FDA Product Code
- FLE
- GMDN Term
- Steam sterilizer
- Device Class
- Class II
- Regulation Number
- 880.6880
- GUDID distribution status
- In Commercial Distribution
Other devices from Steris Mexico, S. de R.L. de C.V.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No