Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

COLOPLAST MANUFACTURING US LLC

MN/USA

2125337

2024

dressing, wound and burn, hydrogel w/drug and/or biologic - WounDres

Manufacturer

bandage, liquid, skin protectant - Atrac-Tain; Barrier Cream; Brava Barrier Cream; Brava Lubricating Deodorant; Brava Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; Coloplast Prep; Comfeel Barrier Cream; Comfeel Cleanser; Derma-Gard Wipe; Isorins; Ostomy Skin Barrier Cream; SeaClens; Shield Skin

Manufacturer

dressing, wound, hydrophilic - Triad Hydrophilic Wound Dressing

Manufacturer

COLOPLAST MANUFACTURING US, LLC

MN/USA

2125050

2024

device, impotence, mechanical/hydraulic - Titan Inflatable Penile Prosthesis; Titan OTR Inflatable Penile Prosthesis; Titan Touch Inflatable Penile Prosthesis

Manufacturer

prosthesis, penile - Genesis Malleable Penile Prosthesis

Manufacturer

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator - Aris Transobturator Kit

Manufacturer

prosthesis, testicular - Saline Filled Testicular Prosthesis; Torosa Testicular Prosthesis

Manufacturer

surgical instruments, g-u, manual (and accessories) - Brooks Dilator Set; Furlow Tool; Gil vernet; Infant Deaver Retractor; Rossello Cavernotome Set; Rossello Rasping Dilator

Specification Developer

Show all 25 Listings for COLOPLAST MANUFACTURING US, LLC MN/USA

Coloplast Manufacturing US, LLC

GA/USA

3012165036

2024

endoscopic guidewire, gastroenterology-urology - Orchestra® Hydrophilic guidewire

Repackager/Relabeler

dressing, wound, occlusive - Band-Aid; Biatain Adhesive; Biatain Non-Adhesive; Biatain Non-Adhesive Foam Dressing; Biatain Silicone; Biatain Silicone Fit; Biatain Silicone Lite; Biatain Silicone Non-Border; Biatain Soft-Hold; Biatain Super; Brava Protective Sheets; Comfeel Plus Contour; Comfeel Plus Transparent; Neutrogena Acne Blemish Patch; Neutrogena Dots Sensitive

Repackager/Relabeler

irrigator, ostomy - Assura Irrigation Pressplate; Assura Irrigation Set; Assura Ostomy Bag; Coloplast Irrigation Colotip; SenSura Mio Hospital Irrigation Set; SenSura Mio Irrigation Sleeve; Sensura Mio Irrigation Sleeves

Repackager/Relabeler

bandage, liquid, skin protectant - Atrac-Tain; Barrier Cream; Brava Barrier Cream; Brava Lubricating Deodorant; Brava Skin Barrier Spray; Brava Skin Barrier Wipe; Brava Skin Cleanser; Coloplast Prep; Comfeel Barrier Cream; Comfeel Cleanser; Derma-Gard Wipe; Isorins; Ostomy Skin Barrier Cream; SeaClens; Shield Skin

Repackager/Relabeler

collector, ostomy - Assura Kit; Assura Night bag; Assura Ostomy Pouch; Assura Urostomy bag; Assura Urostomy Pouch; Brava belt; Brava Belt for SenSura Mio; Brava Elastic Tape; Brava Elastic Tape Belt; Brava Elastic Tape Straight; Brava Lubricant Deodorant; Brava Mouldable Rings; Brava Paste; Brava Powder; Brava Protective Seal; Brava Protective Seal Convex; Brava Strip Paste; Coloplast Clamp; Coloplast Filtrodor; Coloplast Paste; Coloplast Rings; Coloplast Urostomy Night Bag; SenSura Click ostomy bag; SenSura Click Ostomy baseplate; SenSura Click urostomy bag; SenSura Click Xpro ostomy baseplate; SenSura Drainable bag with soft tap; Sensura Flex ostomy bag; Sensura Flex Ostomy baseplate; Sensura Flex urostomy bag; Sensura Flex Xpro ostomy baseplate; Sensura Magnum; SenSura Mio baby ostomy bag; SenSura Mio Baby ostomy baseplate; SenSura Mio Click High Output ostomy bag; SenSura Mio Click Ostomy bag; SenSura Mio Click ostomy baseplate; SenSura Mio Click urostomy bag; SenSura Mio Concave Ostomy bag; SenSura Mio Concave Ostomy baseplate; SenSura Mio Concave Urostomy bag; SenSura Mio Convex High Output ostomy bag; SenSura Mio Deep convex ostomy bag; SenSura Mio Deep convex ostomy baseplate; SenSura Mio Deep convex urostomy bag; Sensura Mio Flex; SenSura Mio Flex High Output ostomy bag; SenSura Mio Flex ostomy bag; SenSura Mio Flex ostomy baseplate; SenSura Mio Flex urostomy bag; SenSura Mio High Output ostomy bag; SenSura Mio Kids Flex ostomy bag; SenSura Mio Kids Flex urostomy bag; SenSura Mio Kids ostomy bag; SenSura Mio Kids ostomy baseplate; SenSura Mio Kids urostomy bag; SenSura Mio Light convex ostomy bag; SenSura Mio Light convex ostomy baseplate; SenSura Mio Light convex urostomy bag; SenSura Mio Original; SenSura Mio ostomy bag; SenSura Mio Post Op ostomy bag; SenSura Mio Soft convex ostomy bag; SenSura Mio Soft convex ostomy baseplate; SenSura Mio Soft convex urostomy bag; SenSura Mio Urostomy bag; SenSura Ostomy bag; SenSura Post Op ostomy bag; SenSura Urostomy bag; SenSura Xpro ostomy bag; SenSura Xpro Urostomy bag

Repackager/Relabeler

Show all 19 Listings for Coloplast Manufacturing US, LLC GA/USA

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Establishment Registration & Device Listing

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