MULTIPLE MANUFACTURED BY TGI DIRECT

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Request for Information Form	Contact Information
Company Name	TGI DIRECT
Address	3085 E. REID RD.
City, State, Zip	GRAND BLANC, MI 48439
Country	US
FDA Owner/Operator Phone	810-239-5553
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DRA
FDA Classification Name	CATHETER, STEERABLE
FDA Device Classification Code	Standards
FDA Regulation Number	870.1280
FDA Common Generic Name	STEERABLE CATHETERS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9103660
FDA Owner / Operator Name	TGI DIRECT
FDA Establishment Registration Number	3006367242
FDA Registered Establishment Name	TGI DIRECT
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	06-25-07
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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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH ST. PAUL, MN 55112 US 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF STEERABLE CATHETERS
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4	GUIDANT IRELAND CASHEL RD. CLONMEL, TIPPERARY, EI 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF STEERABLE CATHETERS
5	GUIDANT PUERTO RICO B.V. #12, RD. #698 DORADO, PR 00646 US 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF STEERABLE CATHETERS
6	HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. MOUNTAIN VIEW, CA 94043 US 650-404-5800 / 650-404-5940	ARTISAN CONTROL CATHETER	STEERABLE GUIDE CATHETER
7	ST. JUDE MEDICAL 14901 DEVEAU PL. MINNETONKA, MN 55345 US 651-483-2000 / 952-351-1544	STEERABLE ELECTROPHYSIOLOGY CATHETER	VARIOUS