MULTIPLE MANUFACTURED BY GYRUS MEDICAL GMBH

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MULTIPLE

Request for Information Form	Contact Information
Company Name	GYRUS MEDICAL GMBH
Address	GOTENSTRASSE 3
City, State, Zip	TUTTLINGEN,
Country	GM
FDA Owner/Operator Phone	011-44-189219750
FDA Medical Specialty Code	OP - Opthalmic
FDA Product Code	HJJ
FDA Classification Name	LENS, FRESNEL, FLEXIBLE, DIAGNOSTIC
FDA Device Classification Code	General Controls
FDA Regulation Number	886.1390
FDA Common Generic Name	VARIOUS TYPES OF FRESNEL DIAGNOSTIC LENSES
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9018965
FDA Owner / Operator Name	GYRUS GROUP PLC
FDA Establishment Registration Number	9680562
FDA Registered Establishment Name	GYRUS MEDICAL GMBH
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	12-14-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of GYRUS MEDICAL GMBH

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	CM INSTRUMENTE GMBH GANSACKER 56 TUTTLINGEN, BW, DE, 78532 GM 49-074-622042061 / 49-074-622042061	CM FLEXIBLE DIAGNOSTIC FRESNEL LENS	FLEXIBLE DIAGNOSTIC FRESNEL LENS
2	DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0	MULTIPLE PRIVATE LABEL	VARIOUS TYPES OF FLEXIBLE DIAGNOSTIC FRESNEL LENS
3	EUGENIA EYEWEAR COMPANY LIMITED 8 YUANZHAI ROAD HUANGYU, SANYANG WENZHOU, ZHEJIANG, 325003 CH 86-577-88562981 / 086-577-88562981	MULTIPLE	FLEXIBLE DIAGNOSTIC FRESNEL LENS
4	FENTEXMEDICAL GMBH TAKE-OFF GEWERBEPARK 4 NEUHAUSEN, BW, D 78579 GM 49-746-7949620 / 49-746-7949620	VARIOUS TYPES OF FRESNEL DIAGNOSTIC LENSES	VARIOUS TYPES OF FRESNEL DIAGNOSTIC LENSES
5	GN OTOMETRICS NORTH AMERICA 125 COMMERCE DR. SCHAUMBURG, IL 60173 US 952-769-8000 / 800-289-2150	FL-15	FRENZEL LENSES
6	JEDMED INSTRUMENT CO. 5416 JEDMED CT. ST. LOUIS, MO 63129 US 314-845-3770 / 314-845-3770 220	FRENZEL GOGGLES	FRENZEL GOGGLES
7	MULTILENS AB SKINNEFJALLSV. 1 MOLNLYCKE, 43450 SW / 46-31-887550	MLPRISMA	PRISM TEST KIT
8	NAGASHIMA MEDICAL INSTRUMENTS CO., LTD. 24-1 HONGO, 5-CHOME BUNKYO-KU, TOKYO, JA 813-381-26555 / 813-381-2-6555	FRENZEL EYEGLASSES	EYEGLASSES USED FOR DETECTING NYSTAGMUS
9	OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 WETZLAR, D-35582 GM 011-496-4120050 / 425-670-9977	LENS, FRESNEL, FLEXIBLE DIAGNOSTIC	DIAGNOSTIC LENS
10	S.A. INSTRUMENTATION DIFRA RUE DE L'EGLISE 84 WELKENRAEDT, 4840 BE 32-87-898080 / 307-637-5711	VIDEOSCOOP, VARIOUS OTHER MODELS	VARIOUS MODELS OF VIDEO FRESNEL GOGGLES

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