BARIUM SULFATE MANUFACTURED BY TEKNIMED SA

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Request for Information Form	Contact Information
Company Name	TEKNIMED SA
Address	11 RUE APOLLO
City, State, Zip	L'UNION,
Country	FR
FDA Owner/Operator Phone	33-5-62968838
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	MYU
FDA Classification Name	ACCESSORY,BARIUM SULFATE,METHYL METHACRYLATE FOR CRANIOPLASTY
FDA Device Classification Code	Standards
FDA Regulation Number	882.5300
FDA Common Generic Name	BARIUM SULFATE
FDA Proprietary Device Name	BARIUM SULFATE
FDA Owner / Operator Number	9040657
FDA Owner / Operator Name	TEKNIMED SA
FDA Establishment Registration Number	9615788
FDA Registered Establishment Name	TEKNIMED SA
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	01-12-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/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	ARTHROCARE CORP. 680 VAQUEROS AVE. SUNNYVALE, CA 94085 US 408-736-0224 / 408-736-0224	TRACERS BONE CEMENT OPACIFIER	ACCESSORY, BARIUM SULFATE, METHYL METHACRYLATE FOR CRANIOPLASTY
2	BRYAN CORP. FOUR PLYMPTON ST. WOBURN, MA 01801 US 781-935-0004 / 781-935-0004	BIOTRACE	BARIUM SULFATE
3	CARDINAL HEALTH 400 EAST FOSTER RD. MANNFORD, OK 74044 US 847-689-8410 / 847-578-6610	ACCESSORY, BARIUM SULFATE, METHYL METHACRYLATE FOR CRANI	BONE CEMENT RADIOPACIFIER
4	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	AVA-TEX	BONE CEMENT RADIOPACIFIER
5	SCIARRA LABORATORIES, INC. 485-09 SOUTH BROADWAY HICKSVILLE, NY 11801 US 516-933-7853 / 516-933-7853	BIOTRCE (R)	BARIUM SULFATE