TBI-1, TBI-80, TBI-BLACK, TBI-WHITE MANUFACTURED BY MANICO BLOOMINGTON

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Request for Information Form	Contact Information
Company Name	MANICO BLOOMINGTON
Address	515 WOODSCREST MEDICAL BLDG., SUITE 001, P.O. BOX 5504
City, State, Zip	BLOOMINGTON, IN 47407
Country	US
FDA Owner/Operator Phone	812-336-2567
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FEJ
FDA Classification Name	ATTACHMENT, BINOCULAR, FOR ENDOSCOPE
FDA Device Classification Code	General Controls
FDA Regulation Number	876.1500
FDA Common Generic Name	TRANSLID BINOCULAR INTERACTOR (TBI)
FDA Proprietary Device Name	TBI-1, TBI-80, TBI-BLACK, TBI-WHITE
FDA Owner / Operator Number	1628366
FDA Owner / Operator Name	MANICO BLOOMINGTON
FDA Establishment Registration Number	1628366
FDA Registered Establishment Name	MANICO BLOOMINGTON
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-01-01
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	ELCON MEDICAL INSTRUMENTS GMBH DR. KARL-STORZ-STRASSE 26A TUTTLINGEN, D-78532 GM 074-61-9281-10 / 49-746-192810	ATTACHMENT, BINOCULAR, FOR ENDOSCOPE	ATTACHMENT, BINOCULAR, FOR ENDOSCOPE
2	RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US 011-49-704335-0 / 847-913-1113 380	MULTIPLE	VARIOUS TYPES AND STYLES OF BINOCULAR ATTACHMENTS
3	WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 SAUERLACH, D-82054 GM 49-810-489080 / 498-104-8908 X16	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED