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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 90 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009940	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103900-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106961-0002	FDA UDI	Class II	Active
Cleanascope/Defendo-Bund	580310	FDA UDI	Class I	Active
The Advantage Polyp Trap-Quad Chamber Polyp Trap	100104	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-200290-0003	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009997	FDA UDI	Class II	Active
Custom Procedure Kit	4002342	FDA UDI	Class II	Active
Custom Procedure Kit	4000705	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200404-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-891800-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200427-0007	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002215	FDA UDI	Class I	Unknown
Preclean Kit	4000900	FDA UDI	Class II	Active
Custom Procedure Kit	4003829	FDA UDI	Class II	Active
Custom Procedure Kit	4000072	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-108673-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103135-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001144	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009369	FDA UDI	Class II	Active
Custom Procedure Kit	4005608	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008392	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006262	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009305	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009367	FDA UDI	Class II	Active
Custom Procedure Kit	4001092	FDA UDI	Class II	Active
Custom Procedure Kit	4005410	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101856	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007852	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103773-0030	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107350-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-101241-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105953-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008858	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102688-0009	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111413-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105701-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010327	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001493	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-645311-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007812	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-104419-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002531	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009875	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007967	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-101215-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003961	FDA UDI	Class II	Active
Endo Carry-on Custom Procedure Kit	4005894	FDA UDI	Class II	Active

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.