Coloplast A/S

Address:HOLTEDAM 1,HUMLEBAEK Hovedstaden,DK

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

COLLECTOR, OSTOMY (EXB) (4) Endoscopic guidewire, gastroenterology-urology (OCY) (4) BAG, DRAINAGE, WITH ADHESIVE, OSTOMY (FON) (2)

Premarket Exempt

No Yes

Clear

Assura - 00762123033777 Catalog Number : 12146

Device Description : Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy Pouch / Ass Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy Pouch / Assura Ostomy pouch. 1-piece closed. Opaque. Midi. Midi. Base Plate Precut Start Hole Size 35 mm, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

Assura - 00762123033784 Catalog Number : 12147

Device Description : Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Ass Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Opaque. Midi. Midi. Base Plate Precut Start Hole Size 40 mm, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

Assura - 00762123033807 Catalog Number : 12149

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 30

Coloplast - 00762123049433 Catalog Number : 14010

Device Description : Coloplast Fistula Bed Drainage Bag. Bed drainage bag.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : FON

Prescription Use : Yes

Device Count : 6

Coloplast - 00762123051078 Catalog Number : 14010

Device Description : Coloplast Fistula Bed Drainage Bag. Bed drainage bag.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : FON

Prescription Use : Yes

Device Count : 10

SenSura Click - 00762123054017 Catalog Number : 10023

Device Description : SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy b SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy baseplate. With belt ears. Coupling Size Diameter 50 mm, Coupling Size Diameter 2 in, Base Plate Precut Start Hole Size 35 mm, Base Plate Max Cut Size 45 mm, Baseplate Max Cut Size 1 3/4 in, Baseplate Precut Start Hole Size 1 3/8 in, Base Plate Type Flat.

Device Class :

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 5

Porges Coloplast - 00884450143292 Catalog Number : AECD35

Device Description : ORCHESTRA® Hydrophilic guidewire, straight, stiff, 3 cm flexible tip

Device Class : 2

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 00884450143315 Catalog Number : AEAD35

Device Description : ORCHESTRA® Hydrophilic guidewire, straight, standard, 3 cm flexible tip

Device Class : 2

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 00884450143322 Catalog Number : AEAE35

Device Description : ORCHESTRA® Hydrophilic guidewire, angled, standard, 3 cm flexible tip

Device Class : 2

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

Porges Coloplast - 00884450143346 Catalog Number : AECE35

Device Description : ORCHESTRA® Hydrophilic guidewire, angled, stiff, 3 cm flexible tip

Device Class : 2

Duns Number: 305524696

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

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