INTRACRANIAL PRESSURE MONITORING SYSTEM MANUFACTURED BY INNERSPACE, INC.

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INTRACRANIAL PRESSURE MONITORING SYSTEM

Request for Information Form	Contact Information
Company Name	INNERSPACE, INC.
Address	1622 EDINGER AVENUE, SUITE C
City, State, Zip	TUSTIN, CA 92780
Country	US
FDA Owner/Operator Phone	714-259-2900
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	OPX-100 INTRACRANIAL PRESSURE (ICP) MONITORING SYSTEM
FDA Proprietary Device Name	INTRACRANIAL PRESSURE MONITORING SYSTEM
FDA Owner / Operator Number	9004095
FDA Owner / Operator Name	INNERSPACE, INC.
FDA Establishment Registration Number	2084683
FDA Registered Establishment Name	INNERSPACE, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-03-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of INNERSPACE, INC.

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	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
13	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
14	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)
15	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
16	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)
17	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
18	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
19	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
20	NEUROSCIENTIFIC CORP. 45 ORCHARD ST. MANHASSET, NY 11030 US 516-671-2400 / 215-946-1300	(TO BE ASSIGNED LATER)	INTRACRANIAL PRESSURE MONITORING SYSTEM
21	NEUROSYSTEMS LLC 103 POMFRET ROAD WOODSTOCK, VT 05091 US 802-457-9866 / 802-457-9866	NEUROSYSTEMS 1	MULTIMODALITY NEUROSURGICAL ICU MONITOR
22	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
23	QPSI, LLC-STERITEK DIVISION 121 MOONACHIE AVE. MOONACHIE, NJ 07074 US 609-784-4831 / 609-784-4831	STERITEK INTRACRANIAL PRESSURE MONITOR	ICP MONITOR
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