BIOTRCE (R) MANUFACTURED BY SCIARRA LABORATORIES, INC.

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Request for Information Form	Contact Information
Company Name	SCIARRA LABORATORIES, INC.
Address	485-09 SOUTH BROADWAY
City, State, Zip	HICKSVILLE, NY 11801
Country	US
FDA Owner/Operator Phone	516-933-7853
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	BIOTRCE (R)
FDA Owner / Operator Number	9040902
FDA Owner / Operator Name	SCIARRA LABORATORIES, INC.
FDA Establishment Registration Number	2436227
FDA Registered Establishment Name	SCIARRA LABORATORIES, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	04-27-00
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	TEKNIMED SA 11 RUE APOLLO L'UNION, 31240 FR 33-5-62968838 / 512-388-0199	BARIUM SULFATE	BARIUM SULFATE