Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008403546

FEI Number

3008403546

Entity Name

CENTURION MEDICAL PRODUCTS, LP

City/State/Country

Williamston, MI, US

Establishment Address

100 Centurion Way, Williamston, MI 48895, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Medline Industries, LP (Owner Number: 1824619)

Owner / Operator Contact Address

Three Lakes Drive, --, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retractor Centurion CirClamp Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri NAMIC Extension Sets NEURO SUCTION TUBING / STERILE Medline Cardiovascular Procedure Kits Medline Integrated Arterial Catheter Flush Connector WINGGUARD SORBAVIEW SHIELD HUBGUARD SECUREVIEW SorbaView SorbaView OTC SiteGuard VersaDerm SorbaView SHEILD Rectal Irrigation Kit Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass NAMIC CLOSED FLUID SYSTEMS; NAMIC CONTRAST REMOVAL VALVE; NAMIC FILLING STATION; NAMIC FILLING STATION PLUS; NAMIC FLUID Occlusion, Umbilical Kits Tracheobronchial suction catheter kit NAMIC CONTRAST MANAGEMENT SYSTEM; NAMIC CONTRAST CONTROLLER; NAMIC SQUEEZE CONTRAST CONTROLLER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2013-02-06
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2008-01-16
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-01-13
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2019-09-17
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2019-09-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-07-25
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-04-19
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-12-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2014-12-01
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2021-12-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-05-19
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-06-19
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2023-07-25
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2016-01-13
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-03-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-11-14
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-27
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2015-04-29
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2015-04-29
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2011-01-13
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2012-05-17
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2016-12-13
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2016-12-13
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2014-02-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-02-28
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-21
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2025-12-11
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2011-01-13
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2011-01-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-09-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-07-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-07-25
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2004-04-06
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2025-12-01
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2008-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2011-01-31
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-07-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-23

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008403546. Last updated year: 2026. Please use registration number 3008403546 when referencing this establishment in official correspondence.