PEEL-AWAY INTRODUCER SHEATH MANUFACTURED BY INTEGRA NEURO SCIENCES

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Request for Information Form	Contact Information
Company Name	INTEGRA NEURO SCIENCES
Address	5955 PACIFIC CENTER BLVD.
City, State, Zip	SAN DIEGO, CA 92121
Country	US
FDA Owner/Operator Phone	609-275-0500
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	HCA
FDA Classification Name	CATHETER, VENTRICULAR
FDA Device Classification Code	Standards
FDA Regulation Number	882.4100
FDA Common Generic Name	INTRODUCER SHEATH
FDA Proprietary Device Name	PEEL-AWAY INTRODUCER SHEATH
FDA Owner / Operator Number	9004007
FDA Owner / Operator Name	INTEGRA LIFESCIENCES CORPORATION
FDA Establishment Registration Number	2023988
FDA Registered Establishment Name	INTEGRA NEURO SCIENCES
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	06-18-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VENTRICULAR CATHETER	VENTRICULAR CATHETER
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5	INTEGRA NEUROSCIENCES PR ROAD 402 NORTH, KM 1.2 ANASCO, PR 00610 US 609-275-0500 / 609-936-2311	MULTIPLE	VARIOUS SITES AND CONFIGURATIONS
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8	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE VENTRICULAR CATHETERS	VARIOUS TYPES OF VENTRICULAR CATHETERS