VARIOUS DESIGNS MANUFACTURED BY DIREX SYSTEMS CORP.

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VARIOUS DESIGNS

Request for Information Form	Contact Information
Company Name	DIREX SYSTEMS CORP.
Address	437 TURNPIKE ST.
City, State, Zip	CANTON, MA 02021
Country	US
FDA Owner/Operator Phone	339-502-6013
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	LNS
FDA Classification Name	LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL
FDA Device Classification Code	Standards
FDA Regulation Number	876.5990
FDA Common Generic Name	LITHOTRIPTER
FDA Proprietary Device Name	VARIOUS DESIGNS
FDA Owner / Operator Number	9024470
FDA Owner / Operator Name	DIREX SYSTEMS CORP.
FDA Establishment Registration Number	1224828
FDA Registered Establishment Name	DIREX SYSTEMS CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-19-95
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of DIREX SYSTEMS CORP.

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	DORNIER MEDTECH SYSTEMS GMBH ARGELSRIEDER FELD 7 WESSLING, D-82234 GM 49-815-3 888 193 / 770-514-6163	MULTIPLE	VARIOUS
2	E.S.W.L. PRODUCTS, INC. 1542 BARCLAY BLVD. BUFFALO GROVE, IL 60089 US 847-419-6844 / 847-419-6844	LITHOWAVE	EXTRACORPOREAL SHOCKWAVE LITOTRIPTOR
3	FMD, LLC 7200-E TELEGRAPH SQUARE DR. LORTON, VA 22079 US 703-880-4642 / 703-880-4642	TWINHEADS TH-103	EXTRACORPOREAL SHOCK-WAVE LITHOTRIPTOR
4	HEALTH TRONICS, INC. 300 TOWN PARK DR. SUITE 260 KENNESAW, GA 30144 US 678-921-4431 / 678-569-0436	MULTIPLE	EXTRACORPOREAL SHOCK WAVE UROLOGICAL
5	MEDISPEC, LTD. 40 HATAASIYA ST. P.O. BOX 292 YEHUD, 56101 IS 972-363-22003 / 301-944-1575 222	ECONOLITH EM1000, E3000, E2000	EXTRACORPOREAL SHOCK WAVE LITHOTRIPTOR
6	MEDISPEC, LTD. 20410 OBSERVATION DRIVE, SUITE 102 GERMANTOWN, MD 20876 US 972-363-22003 / 301-944-1575 222	ECONOLITH	ESTRACORPOREAL SHOCK-WAVE LITHOTRIPTER
7	MTS EUROPE GMBH ROBERT-BOSCH-STRASSE 18 KONSTANZ, 78467 GM 49-753-13618561 / 49-753-13618561	LITHOGOLD	LITHOGOLD
8	PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. 1 ORG SANAYI BOLGES ORHAN ISIK CAD 4 SINCAN ANKARA, 06935 TU 90-312-2672046 / 90-312-2672046	STONELITH V5	EXTRACORPEAL SHOCK-WAVE LITHOTRIPTOR
9	RICHARD WOLF GMBH PFORZHEIMER STR. 32 KNITTLINGEN, 75438 GM 011-49-704335-0 / 847-913-1113 380	LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE	LITHOTRIPTOR
10	RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US 011-49-704335-0 / 847-913-1113 380	LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE	LITHOTRIPTOR
11	SIEMENS AG, MEDICAL SOLUTIONS ROENTGENSTRASSE 2 RUDOLSTADT, 07407 GM / 610-448-4153	MULTIPLE	LITHOTRIPSY UNIT
12	SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN, 91052 GM / 610-448-4153	MULTIPLE	LITHOTRIPSY UNIT
13	STORZ MEDICAL AG LOHSTAMPFESTRASSE 8 TAGERWILEN, CH-8274 SZ 41-071-677 45 45 / 678-354-6229 8812	STORZ MODULITH LITHOTRIPTOR, MODEL SL-20 AND SLX	EXTRACORPOREAL SHOCKWAVE LITHOTRIPTER
14	TECHNOMED MEDICAL SYSTEMS, SA 4-6 RUE DU DAUPHINE VAULX-EN-VELIN, 69120 FR 334-72-15 31 50 / 33-47-2153150	MULTIPLE	MULTIPLE
15	VALMED, INC. 221 SPRING ST. SHREWSBURY, MA 01545 US 508-845-3438 / 508-845-3438	HOFFMANN MEDIZINISCHE TECHNIK 20/500 SHOCK PLUG	LITHOTRIPTER ELECTRODE