Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222313

FEI Number

1000121050

Entity Name

PROFESSIONAL CONTRACT STERILIZATION, INC.

City/State/Country

Taunton, MA, US

Establishment Address

40 Myles Standish Blvd, Taunton, MA 02780, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Professional Contract Sterilization, Inc. (Owner Number: 10043067)

Owner / Operator Contact Address

40 Myles Standish Blvd, Taunton, MA 02780, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CM Trauma Bandage 4 Flat Packed NAR EMERGENCY TRAUMA DRESSING (ETD) 4" FLAT NAR EMERGENCY TRAUMA DRESSING (ETD) ABD NAR EMERGENCY TRAUMA DRESSING (ETD) 4" NAR EMERGENCY TRAUMA DRESSING NAR Compression ETD 8"x10" Flat NAR EMERGENCY TRAUMA DRESSING (ETD) 6" NAR EMERGENCY TRAUMA DRESSING (ETD) 6" FLAT Radiology Kit Spear Spong NAR S-Rolled Gauze NAR Responder Compressed Gauze NAR Compressed Gauze TruClear Dense Tissue Mini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-01-30
DRC	Trocar	Cardiovascular	Class 2	870.1390	2021-01-05
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-04-27
OIP	Radiology-Diagnostic Kit	Radiology	Class 2	892.1680	2024-06-18
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2024-06-18
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-05-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-01-30
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-04-22

Official Correspondent

Gary Cranston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Professional Contract Sterilization, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222313. Last updated year: 2026. Please use registration number 1222313 when referencing this establishment in official correspondence.