Question 1

Where is Stericube, LLC located and what types of products do they manufacture?

Accepted Answer

Stericube, LLC is based in the United States. The company specializes in the manufacturing of reusable sterilization and disinfection containers, chemical and physical sterilization process indicators, and single-use sterilization container filters. Their product line includes various cabinets and transfer carts that are specifically designed to be compatible with sterilization systems from manufacturers such as STERIS and Getinge.

Question 2

How are the medical devices from Stericube, LLC classified?

Accepted Answer

The medical devices manufactured by Stericube, LLC are classified as Class II devices. This classification is based on the regulatory framework applied to their portfolio of sterilization containers, process indicators, and filtration components, which are subject to specific regulatory requirements for safety and effectiveness.

Question 3

Which regulatory registries include the devices produced by Stericube, LLC?

Accepted Answer

The devices produced by Stericube, LLC are listed in the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system. These listings provide transparency regarding the regulatory status of their specific products, as individual devices must be authorized through these systems to be marketed in the United States.

Device	Model / Reference	Registries	Class	Status
STERIS Evolution Bridge	MTS-BR-EVO	FDA UDI	Class II	Active
MTS225 GETINGE Cabinet	MTS-225-CAB-GET-1	FDA UDI	Class II	Active
MTS300 Transfer Cart, FL, Universal	MTS300 Transfer Cart MTS-TC-FL	FDA UDI	Class II	Active
SteriCUBE 225 Transfer Cart, STERIS 600	MTS225-STR-1 TC	FDA UDI	Class II	Active
MTS225 GETINGE Transfer Cart	MTS-225-TC-GET-1	FDA UDI	Class II	Active
MTS300 Transfer Cart, Steris, Standard	MTS300 Transfer Cart STR-1R	FDA UDI	Class II	Active
MTS300 Cabinet, Getinge	MTS300 Cabinet GET-1	FDA UDI	Class II	Active
SteriCUBE 225 Cabinet, STERIS 600	MTS225-STR-1 CAB	FDA UDI	Class II	Active
MTS300 Transfer Cart, Getinge	MTS300 Transfer Cart, GET-1	FDA UDI	Class II	Active
MTS300 Transfer Cart, Steris, Standard	MTS300 Transfer Cart STR-1	FDA UDI	Class II	Active
MTS300 Transfer Cart, Steris, Evolution	MTS300 Transfer Cart STR-2	FDA UDI	Class II	Active
MTS Filter Kit	MTS-FLT-25PACK	FDA UDI	Class II	Active
MTS300 Cabinet, Steris, Evolution	MTS300 Cabinet STR-2	FDA UDI	Class II	Active
MTS300 Transfer Cart, Steris, Standard	MTS300 Transfer Cart STR-0	FDA UDI	Class II	Active
MTS300 Filter Kit	MTS300-Filters	FDA UDI	Class II	Active
MTS300 Cabinet, Steris, Standard	MTS300 Cabinet STR-1	FDA UDI	Class II	Active
MTS300 Cabinet, Steris, Standard	MTS300 Cabinet STR-0	FDA UDI	Class II	Active
GETINGE Bridge	MTS-BR-GET	FDA UDI	Class II	Active
MTS225 STERIS Transfer Cart	MTS-225-TC-STR-1	FDA UDI	Class II	Active
MTS300 Floor Loader, Getinge	MTS300 Floor Loader GET-FL	FDA UDI	Class II	Active
MTS225 Cabinet	MTS-225-CAB	FDA UDI	Class II	Active
MTS300 Cabinet, Steris, Standard	MTS300 Cabinet STR-1R	FDA UDI	Class II	Active
MTS225 TCFL Transfer Cart	MTS-225-TC-TCFL	FDA UDI	Class II	Active
SteriCUBE Filter Kit +	SteriCUBE-PACK-025-FCSKIT	FDA UDI	Class II	Active
STERIS Bridge	MTS-BR-STR	FDA UDI	Class II	Active
SteriCUBE® Multiple Tray Sterilization Systems	K222328	FDA 510(k)	Class II	Active

Stericube, LLC

What Stericube, LLC makes

Frequently asked questions

Information

Catalogue (26)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities