DOYEN MYOMA SCREW MANUFACTURED BY ELCON MEDICAL INSTRUMENTS GMBH

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Request for Information Form	Contact Information
Company Name	ELCON MEDICAL INSTRUMENTS GMBH
Address	DR. KARL-STORZ-STRASSE 26A
City, State, Zip	TUTTLINGEN,
Country	GM
FDA Owner/Operator Phone	074-61-9281-10
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	HHO
FDA Classification Name	SCREW, FIBROID, GYNECOLOGICAL
FDA Device Classification Code	Standards
FDA Regulation Number	884.4530
FDA Common Generic Name	DOYEN MYOMA SCREW
FDA Proprietary Device Name	DOYEN MYOMA SCREW
FDA Owner / Operator Number	9003951
FDA Owner / Operator Name	ELCON MEDICAL INSTRUMENTS GMBH
FDA Establishment Registration Number	8043816
FDA Registered Establishment Name	ELCON MEDICAL INSTRUMENTS GMBH
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	11-15-04
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	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891	HYSTEROSCOPE & LAPAROSCOPE MYOMA SCREW
3	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	DOYEN MYOMA SCREW	DOYEN MYOMA SCREW
4	DUFNER INSTRUMENTE GMBH FOEHRENSTR. 9 TUTTLINGEN, 78532 GM 011-49-74613697 / 011-493-74613697	MYOMA SCREW	SAME
5	GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900	MULTIPLE	SCREW
6	HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. CHICAGO, IL 60618 US 773-975-6100 / 773-975-6100	VARIOUS	FIBROID SCREW
7	MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090	SCREW, FIBROID, GYNECOLOGICAL	MYOMA SCREW
8	MILTEX GMBH MUEHLSTRASSE 6 RIETHEIM- WEILHEIM, D-78604 GM 609-275-0500 / 717-840-3409	MILTEX	DOYEN FIBROID SCREW
9	MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409	MILTEX	DOYEN FIBROID SCREW
10	TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. SATTLERSTRASSE 11 NENDINGEN, TUTTLINGEN-16, D-78532 GM 004-974-61 1701 0 / 004-974-61 1701 0	TEKNO	SCREW, FIBROID, GYNECOLOGICAL