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MEDIVATORS INC.

United States·US-MF-000043422

Last updated September 17, 2026

Information

Country: United States
Address: 3150, Pollok Dr, Conroe, United States
Website: www.steris.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)444-4729
PRRC Contact: Zeeshan Shamim
EUDAMED SRN: US-MF-000043422
FDA FEI Number: 3003012447
DUNS Number: 068199363

Catalogue (5153)

Page 73 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	102938	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006135	FDA UDI	Class II	Active
Rapicide Pa Part A 3x5	ML02-PTA13	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001915	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009806	FDA UDI	Class II	Active
Preclean Kit	4000892	FDA UDI	Class II	Active
Custom Procedure Kit	4000985	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002565	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104398-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003131	FDA UDI	Class II	Active
Custom Procedure Kit	4000671	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100870	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104854-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002172	FDA UDI	Class I	Unknown
Endogator Kit	4005471	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110854-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008317	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-329000-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-653000-0002	FDA UDI	Class I	Unknown
ENDOGATOR hybrid irrigation tubing	100608	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009064	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-500175-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100966	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106359-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100871	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105144-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101824	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000059	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200165-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100746-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101966	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200453-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-369030-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Custom Procedure Kit	4005904	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000876	FDA UDI	Class I	Unknown
Pull Thru Cassette Wall Mount	4002594	FDA UDI	Class I	Active
Endo-Carry-on Procedure Kit	4008148	FDA UDI	Class II	Active
Custom Procedure Kit	4000161	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001489	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008211	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008757	FDA UDI	Class II	Active
Renasol Acid Concentrate	SB-1086	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-102688-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103900-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108667-0001	FDA UDI	Class I	Unknown
Mini Pull Thru	Mini Pull Thru Brush	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-105189-0002	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

STERIS Ireland Ltd IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 20, 2021	Z-1859-2021	—	terminated	The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Oct 9, 2019	Z-1775-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1777-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1774-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1773-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1776-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1772-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1778-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Aug 3, 2015	Z-2761-2015	—	terminated	Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.