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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CONVEEN OPTIMA; CONVEEN SECURITY +; FREEDOM BRAND; GIZMO; Penilex; Self-Cath Extension Tube; ULTRA SECURE; ULTRA SECURE MALE EXTERNAL CATHETER; URO-SAN
Classification Name: DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
Product Code: NNX
Device Class: 1
Regulation Number: 876.5250
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST HUNGARY KFT
Registered Establishment Number: 3006606901
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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