TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET (LCB) MANUFACTURED BY ACCELLENT INC.

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Request for Information Form	Contact Information
Company Name	ACCELLENT INC.
Address	1526-6 CALLE HERTZ
City, State, Zip	JUAREZ, CHIHUAHUA,
Country	MX
FDA Owner/Operator Phone	866-899-1392
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	LQC
FDA Classification Name	LITHOTRIPTOR, BILIARY MECHANICAL
FDA Device Classification Code	Standards
FDA Regulation Number	876.4500
FDA Common Generic Name	RETRIEVAL BASKET/LITHOTRIPSY BASKET
FDA Proprietary Device Name	TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET (LCB)
FDA Owner / Operator Number	9048369
FDA Owner / Operator Name	ACCELLENT INC.
FDA Establishment Registration Number	9680001
FDA Registered Establishment Name	ACCELLENT INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer MS - Specification Developer
FDA Listing Date	01-24-06
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	AOMORI OLYMPUS CO., LTD. 2-248-1, OKKONOKI KUROISHI-SHI, AOMORI-KEN, 036-0357 JA / 484-896-5688	MECHANICAL LITHOTRIPTOR	MECHANICAL LITHOTRIPTOR
2	COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. WINSTON-SALEM, NC 27105 US 336-744-0157 / 336-744-0157	SAME	SOEHENDRA LITHOTRIPSY SET
3	MEDI-GLOBE GMBH MEDI-GLOBE-STRASSE, 1-5 ACHENMUHLE, D-83101 GM 49-803-29730 / 480-897-2772 208	MULTIPLE	VARIOUS TYPES OF BILIARY MECHANICAL LITHOTRIPTER AND ACCES.
4	OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688	MECHANICAL LITHOTRIPTOR	MECHANICAL LITHOTRIPTOR
5	SCANDIMED INTERNATIONAL 409 SLOTSHERRENSVEJ GLOSTROP, DK 2600 DA 004-544-926444 / 004-544-966444	LITHOTRIPSY & BASKETS	VARIOUS TYPES OF BASKETS