TUNNELER, PERITONEAL INTRODUCER MANUFACTURED BY INTEGRA NEUROSCIENCES IMPLANTS S.A.

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TUNNELER, PERITONEAL INTRODUCER

Request for Information Form	Contact Information
Company Name	INTEGRA NEUROSCIENCES IMPLANTS S.A.
Address	2905 ROUTE DES DOLINES
City, State, Zip	SOPHIA ANTIPOLIS,
Country	FR
FDA Owner/Operator Phone	609-275-0500
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	GYK
FDA Classification Name	INSTRUMENT, SHUNT SYSTEM IMPLANTATION
FDA Device Classification Code	General Controls
FDA Regulation Number	882.4545
FDA Common Generic Name	TUNNELER, PERITONEAL INTRODUCER
FDA Proprietary Device Name	TUNNELER, PERITONEAL INTRODUCER
FDA Owner / Operator Number	9004007
FDA Owner / Operator Name	INTEGRA LIFESCIENCES CORPORATION
FDA Establishment Registration Number	9612007
FDA Registered Establishment Name	INTEGRA NEUROSCIENCES IMPLANTS S.A.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	09-25-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of INTEGRA NEUROSCIENCES IMPLANTS S.A.

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	MINOP DISPOSABLE INTRODUCER	SHUNT SYSTEM IMPLANTATION INSTRUMENT
2	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1240 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	MULTIPLE	VARIOUS TYPES OF IMPLANTATION INSTRUMENTS
3	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 5 SUNNEN DR. ST. LOUIS, MO 63143 US 847-689-8410 / 847-578-6442	MULTIPLE	VARIOUS TYPES OF IMPLANTATION INSTRUMENTS
4	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	MULTIPLE	VARIOUS TYPES OF IMPLANTATION INSTRUMENTS
5	CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3704 / 508-828-3704	MULTIPLE	INSTRUMENTS FOR SHUNT SYSTEM IMPLANTATION
6	CODMAN AND SHURTLEFF, INC. 50 SCOTLAND PARK DRIVE BRIDGEWATER, MA 02324 US 508-828-3704 / 508-828-3704	MULTIPLE	INSTRUMENTS FOR SHUNT SYSTEM IMPLANTATION
7	INTEGRA NEUROSCIENCES PR ROAD 402 NORTH, KM 1.2 ANASCO, PR 00610 US 609-275-0500 / 609-936-2311	MULTIPLE	VARIOUS STYLES OF INSTRUMENTS
8	MEDOS SARL RUE GIRARDET 29 LE LOCLE, CH-2400 SZ 508-828-3704 / 508-828-3704	MULTIPLE	INSTRUMENTS FOR SHUNT SYSTEM IMPLANTATION
9	MEDTRONIC NEUROSURGERY 125 CREMONA DR. GOLETA, CA 93117 US 763-514-4000 / 805-968-1546 1770	PS MEDICAL DISPOSABLE SUBCUTANEOUS CATHETER PASSER	SHUNT SYSTEM IMLANTATION INSTRUMENT
10	SOPHYSA SA 22 RUE JEAN ROSTAND PARC CLUB ORSAY UNIVERSITE ORSAY, CEDEX, 91893 FR 33-169-353500 / 33-169-353500	TUN45, TUN65, TUG45, TUG65	TWO MODELS OF TUNNELING IMPLANTATION INSTRUMENTS. TWO MODELS OF TUNNELING SHEATH
11	VYGON NEURO 2495 GENERAL ARMISTEAD AVE. NORRISTOWN, PA 19403 US 610-539-9300 / 610-539-9300 110	SHUNT INTRODUCER (MODIFICATION)	NONE GIVEN
12	WELLONG INSTRUMENTS CO., LTD. F3, NO. 1, LANE 43, CHANG-AN EAST RD., SEC. 1 TAIPEI, 10442 TW 886-2-2571-9829 / 886-3-5208829	WEELONG	SHUNTING SYSTEM