STERITEK INTRACRANIAL PRESSURE MONITOR MANUFACTURED BY QPSI, LLC-STERITEK DIVISION

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STERITEK INTRACRANIAL PRESSURE MONITOR

Request for Information Form	Contact Information
Company Name	QPSI, LLC-STERITEK DIVISION
Address	121 MOONACHIE AVE.
City, State, Zip	MOONACHIE, NJ 07074
Country	US
FDA Owner/Operator Phone	609-784-4831
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	GWM
FDA Classification Name	DEVICE, MONITORING, INTRACRANIAL PRESSURE
FDA Device Classification Code	Standards
FDA Regulation Number	882.1620
FDA Common Generic Name	ICP MONITOR
FDA Proprietary Device Name	STERITEK INTRACRANIAL PRESSURE MONITOR
FDA Owner / Operator Number	9067895
FDA Owner / Operator Name	QUALITY PACKAGING SPECIALISTS INTERNATIONAL, INC.
FDA Establishment Registration Number	2248133
FDA Registered Establishment Name	QPSI, LLC-STERITEK DIVISION
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-14-94
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of QPSI, LLC-STERITEK DIVISION

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	AESCULAP BRAIN PRESSURE MONITOR	CRANIAL PRESSURE MONITOR
2	CMA MICRODIALYSIS AB DALVAGEN 10 SOLNA, SE 171 18 SW 468-470-1000 / 978-251-1940 30	CMA 600 NEUROMONITORING SYSTEM, CEREBRAL TISSUE MONITOR	NEUROMONITORING SYSTEM AND ACCESSORIEES
3	CODMAN MAYBACHSTRASSE 10 TUTTLINGEN, 78532 GM 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS INTRACRANIAL PRESSURE MONITORING DEVICES & ACCESSORIES
4	CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS INTRACRANIAL PRESSURE MONITORING DEVICES & ACCESSORIES
5	CODMAN AND SHURTLEFF, INC. 50 SCOTLAND PARK DRIVE BRIDGEWATER, MA 02324 US 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS INTRACRANIAL PRESSURE MONITORING DEVICES AND ACCESSORIES
6	CODMAN, S'ARL RUE GIRARDET 29 LE LOCLE, CH-2400 SZ 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS INTRACRANIAL PRESSURE MONITORING DEVICES & ACCESSORIES
7	FLOWTRONICS, INC. 10250 NORTH 19TH AVE., STE. B PHOENIX, AZ 85021 US 602-997-1364 / 602-997-1364	SIMULTANEOUS THERMAL DIFFUSION BLOOD FLOW/PRESSURE PROBE	SIMULTANEOUS THERMAL DIFFUSION BLOOD FLOW/PRESSURE PROBE (STDBF/PP)
8	GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M DORFSTRABE 2A KIEL-MIELKENDORF, 24247 GM 609-275-0500 / 609-936-2311	LICOX BRAIN OXYGEN MONITORING SYSTEMS, CATHETER PROBES AND KIT	BRAIN OXYGEN AND TEMPERATURE MONITORING DEVICES
9	HEMEDEX INCORPORATED 222 THIRD ST., SUITE 0123 CAMBRIDGE, MA 02142 US 617-577-1759 / 617-577-1759	HEMEDEX CRANIAL BOLT, MODELS 3601, SINGLE LUMEN, 3602 DUAL LUMEN	SINGLE AND DUAL LUMEN CRANIAL BOLT
10	INFRASCAN, INC. 3508 MARKET ST., SUITE 215 PHILADELPHIA, PA 19104 US 215-387-6784 / 215-387-6784	INFRASCANNER	HANDHELD BRAIN HEMATOMA DETECTOR
11	INMED S.A. CORDILLERA 451 QUILICURA, SANTIAGO, CI 562-435-1818 X 143 / 678-908-8180	NEURO SUC (NS107, NS110)	NEUROSURGICAL CLOSED DRAINAGE SYSTEM
12	INNERSPACE, INC. 1622 EDINGER AVENUE, SUITE C TUSTIN, CA 92780 US 714-259-2900 / 714-259-7900	INTRACRANIAL PRESSURE MONITORING SYSTEM	OPX-100 INTRACRANIAL PRESSURE (ICP) MONITORING SYSTEM
13	INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 US 609-275-0500 / 609-936-2311	INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM	NEUROLOGICAL DIAGNOSTIC DEVICE
14	INTEGRA NEURO SCIENCES 5955 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 US 609-275-0500 / 858-455-1115 115	CAMINO OR VENTRIX INTRACRANIAL PRESSURE MONITORING KIT	INTRACRANIAL PRESSURE MONITORING KIT
15	INTEGRA NEUROSCIENCES IMPLANTS S.A. 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS, F-06921 FR 609-275-0500 / 609-936-2311	INTRACRANIAL PRESSURE MONITORING CUP CATHETER,PRESSURE TRANSDUCER	VARIOUS TYPES(STERILE)
16	INTEGRA NEUROSCIENCES, LTD. NEWBURY RD. ANDOVER HAMPSHIRE, SP104DR UK 609-275-0500 / 609-936-2311	CAMINO OR VENTRIX INTRACRANIAL PRESSURE MONITOR	CAMINO OR VENTRIX INTRACRANIAL PRESSURE MONITOR
17	MEDEX DE MEXICO, S.A. DE C.V. CARRETERA MIGUEL ALEMAN,KM21.7 APODACA, NL, 66600 MX 114-420-8-458-3232 / 619-710-1104	C.I.P.E.R.	INTRACRANIAL PRESSURE MONITORING DEVICES (VARIOUS TYPES AND SIZES)
18	MEDICAL MEASUREMENTS, INC. 56 LINDEN ST. HACKENSACK, NJ 07601 US 201-489-9400 / 201-489-9400	MMI/GAELTEC MODEL ICT/B ICP TRANSDUCER	MMI/GAELTEC MODEL ICT/B ICP TRANSDUCER
19	MEDTRONIC NEUROSURGERY 125 CREMONA DR. GOLETA, CA 93117 US 763-514-4000 / 805-968-1546 1770	MULTIPLE MODELS	MULTIPLE TYPES OF INTRACRANIAL PRESSURE MONITORING DEVICES
20	NEURORECOVERY, INC. 6075 POPLAR AVE., SUITE 930 MEMPHIS, TN 38119 US 901-537-2992 / 901-537-2992	NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY, NEURORECOVERY COMPREHE	VENTRICULAR CATHETER & ACCESSORIES, INTRACRANIAL PRESSURE MONITORING DEVICE & AC
21	NEUROSCIENTIFIC CORP. 45 ORCHARD ST. MANHASSET, NY 11030 US 516-671-2400 / 215-946-1300	(TO BE ASSIGNED LATER)	INTRACRANIAL PRESSURE MONITORING SYSTEM
22	NEUROSYSTEMS LLC 103 POMFRET ROAD WOODSTOCK, VT 05091 US 802-457-9866 / 802-457-9866	NEUROSYSTEMS 1	MULTIMODALITY NEUROSURGICAL ICU MONITOR
23	NOVUS MONITORING LTD GREENWAYS, ABBOTTS ANN ANDOVER, HAMPSHIRE, SP11 7BH UK 44-126-4711080 / 44-126-4711080	NEUROSENSOR	CEREBRAL BLOOD FLOW AND INTRCRANIAL PRESSURE MONITORING SYSTEM
24	SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. DUBLIN, OH 43016 US 114-420-8-458-3232 / 614-791-5568	C.I.P.E.R.	INTRACRANIAL PRESSURE MONITORING DEVICES (VARIOUS TYPES AND SIZES)
25	VYGON NEURO 2495 GENERAL ARMISTEAD AVE. NORRISTOWN, PA 19403 US 610-539-9300 / 610-539-9300 110	PHILLY BOLT	VARIOUS