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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: RE-TRACE URETERAL ACCESS SHEATH
Classification Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
Product Code: FED
Device Class: 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST MANUFACTURING FRANCE, SAS
Registered Establishment Number: 9610711
Premarket Submission Number: K140523
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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