MULTIPLE MANUFACTURED BY BIODEX MEDICAL SYSTEMS, INC.

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Request for Information Form	Contact Information
Company Name	BIODEX MEDICAL SYSTEMS, INC.
Address	20 RAMSAY RD.
City, State, Zip	SHIRLEY, NY 11967
Country	US
FDA Owner/Operator Phone	631-924-9000
FDA Medical Specialty Code	RA - Radiology
FDA Product Code	KPT
FDA Classification Name	CALIBRATOR, DOSE, RADIONUCLIDE
FDA Device Classification Code	Standards
FDA Regulation Number	892.1360
FDA Common Generic Name	DOSE CALIBRATOR
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	2431314
FDA Owner / Operator Name	BIODEX MEDICAL SYSTEMS, INC.
FDA Establishment Registration Number	2431314
FDA Registered Establishment Name	BIODEX MEDICAL SYSTEMS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	04-28-93
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	CAPINTEC, INC. 620 ALPHA DR. PITTSBURGH, PA 15238 US 412-963-1988 / 412-963-1988	CAPINTEC RADIOISOTOPE CALIBRATOR	VARIOUS TYPES OF RADIOISOTOPE CALIBRATORS
2	COMECER SPA 390 EMILIA PONENTE CASTELBOLOGNESE (RA), 40026 IT 39-054-6656375 / 410-451-0639	COMECER DOSE CALIBRATOR	DOSE CALIBRATOR
3	FLUKE BIOMEDICAL, LLC 6045 COCHRAN RD. SOLON, OH 44139 US 425-347-6100 / 440-498-2579	CAL-RAD MARK VI, VDC-505 DOSE CALIBRATOR, MODEL 34	DOSE CALIBRATOR
4	MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. BALDWIN PARK, CA 91706 US 626-960-9822 / 626-960-9822	XENO-CAL, MODEL XE-101	DOSE CALIBRATOR
5	MILLS BIOPHARMACEUTICALS, LLC 120 N.E. 26TH ST. OKLAHOMA CITY, OK 73105 US 206-926-2301 / 405-523-1868	MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION	AUTOMATIC NEEDLE LOADING SYSTEM
6	QSA-GLOBAL INC. 40 NORTH AVE. BURLINGTON, MA 01803 US 44-148-1 745001 / 781-272-2000 210	CALIBRATOR, DOSE, RADIONUCLIDE	CALIBRATOR, DOSE, RADIONUCLIDE
7	STANDARD IMAGING, INC. 3120 DEMING WAY MIDDLETON, WI 53562 US 608-831-0025 / 608-831-0025 262	MULTIPLE HDR 1000, HDR 1000 PLUS, IVB 1000, PT1000, ECLIPSE	WELL CHAMBER
8	SUN NUCLEAR CORP. 425-A PINEDA COURT MELBOURNE, FL 32940 US 321-259-6862 / 321-259-6862	ATOMLAB DOSE CALIBRATOR	VARIOUS ATOMLAB DOSE CALIBRATORS:MODELS 1070,1071,1072 AND 1076