MICRO PLEX TM COIL SYSTEM (MCS) HYDROCOIL R EMBOLIC SYSTEM(HES) MANUFACTURED BY ACCELLENT INC.

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MICRO PLEX TM COIL SYSTEM (MCS) HYDROCOIL R EMBOLIC SYSTEM(HES)

Request for Information Form	Contact Information
Company Name	ACCELLENT INC.
Address	1526-6 CALLE HERTZ
City, State, Zip	JUAREZ, CHIHUAHUA,
Country	MX
FDA Owner/Operator Phone	866-899-1392
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	HCG
FDA Classification Name	DEVICE, NEUROVASCULAR EMBOLIZATION
FDA Device Classification Code	Standards
FDA Regulation Number	882.5950
FDA Common Generic Name	EMBOLIZATION COIL
FDA Proprietary Device Name	MICRO PLEX TM COIL SYSTEM (MCS) HYDROCOIL R EMBOLIC SYSTEM(HES)
FDA Owner / Operator Number	9048369
FDA Owner / Operator Name	ACCELLENT INC.
FDA Establishment Registration Number	9680001
FDA Registered Establishment Name	ACCELLENT INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer
FDA Listing Date	09-28-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ACCELLENT 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	ACCELLENT EL PASO 31-C BUTTERFIELD TRAIL EL PASO, TX 79906 US 866-899-1392 / 915-782-1944	MICRO PLEX TM COIL SYSTEM (MCS) HYDROCOIL R EMBOLIC SYSTEM(HES)	EMBOLIZATION COIL
2	ADVANCED MEDICAL SYSTEMS, INC. 2950 N. GLASSELL ST. ORANGE, CA 92865 US 714-998-0085 / 714-998-0085	EARLY DETECTOR, EARLY DETECT	OTC TEST FOR DETERMINATION OF HCG IN URINE
3	BIOCOMPATIBLES U.K. LIMITED CHAPMAN HOUSE, FARNHAM BUS. PARK, WEYDON LN FARNHAM, SURREY ENGLAND, GU9 8QL UK 441-252-732732 / 954-680-2548	LC BEADS,BEADBLOCK	VASCULAR EMBOLIZATION DEVICE,ARTIFICIAL EMBOLIZATION DEVICE;
4	BIOCURE, INC. 2975 GATEWAY DRIVE, SUITE 100 NORCROSS, GA 30071 US 678-966-3400 / 678-966-3408	GELSPHERES-BEAD BLOCK	ARTIFICIAL EMBOLIZATION DEVICE
5	BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. ROCKLAND, MA 02370 US 781-681-7900 / 781-681-7900	EMBOSHPERE (R) MICROSHPHERES	EMBOLIZATION DEVICE
6	BIOSPHERE MEDICAL, S.A. BAT.A.PARC DE NATIONS, PARIS NORD 2 383 RUE DE LA BELLE ETOLLE ROSSY CH DE GAULLE CEDE, 95958 FR 781-681-7900 / 781-681-7900	EMBOGOLD MICROSPHERES/EMBOSPHERE MICROSPHERE	ARTIFICIAL EMBOLI
7	BOSTON SCIENTIFIC CORK LTD. MODEL FARM RD. CORK, EI 508-652-5594 / 508-652-5594	GUGLIELMI DETACHABLE COIL IV (SYNERGY)	DETACHABLE EMOLIC COIL
8	BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY FREMONT, CA 94538 US 508-652-5594 / 508-652-5594	CONTOUR	SPHERES OR EMBOLI
9	BOSTON SCIENTIFIC CORPORATION 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US 508-652-5594 / 508-652-5594	CONTOUR SE	SPHERES OR EMBOLI
10	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	DETACH 11 AND DETACH 18	NEUROLOGICAL ARTERIAL EMBOLIZATION DEVICE
11	CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. MIAMI LAKES, FL 33014 US 786-313-6550 / 786-313-6511	TRUFILL PVA PATICLES	EMBOLIZATION DEVICE
12	EARLY DETECT, INC. 2950 NORTH GLASSELL ST. ORANGE, CA 92865 US 714-283-5190 / 714-283-5190	KNOW NOW PREGNANCY WAND	FOR THE DETERMINATION OF HCG IN URINE
13	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698	SIDE BRANCH OCCLUSION SYSTEM	SIDE BRANCH OCCLUSION SYSTEM
14	EV3 NEUROVASCULAR 9775 TOLEDO WAY IRVINE, CA 92618 US 949-837-3700 1237 / 949-680-1237	NEXUS DETACHABLE COIL SYSTEM	NEUROVASCULAR EMBOLIZATION DEVICE
15	MICROVENTION, INC. 75 COLUMBIA ALISO VIEJO, CA 92656 US 81-333-748111 / 949-461-3314 105	MICROPLEX COIL SYSTEM AND HYDROCOIL EMBOLIC SYSTEM	EMBOLIZATION COIL
16	MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE SAN JOSE, CA 95131 US 408-433-1460 / 408-433-1460	MICRUS MICROCOIL DELIVERY SYSTEM	EMBOLIZATION COIL
17	PROTEIN POLYMER TECHNOLOGIES, INC. 10655 SORRENTO VALLEY RD. SAN DIEGO, CA 92121 US 858-558-6064 / 858-558-6064 151	PVA PLUS(TM),MAXISTAT(TM) PVA,MICROSTAT(TM) FOAM EMBOLIZATION PARTICLES	VARIOUS TYPES OF PVA EMBOLIZATION PARTICLES
18	SURGICA CORP. 5090 ROBERT J. MATHEWS PKWY. #4 EL DORADO HILLS, CA 95762 US 916-933-5056 / 916-933-5056	MULTIPLE	PVA FOAM EMBOLIZATION PARTICLES