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

CATHETER, STRAIGHT (EZD) (10)

Premarket Exempt

No Yes

Clear

Self Cath - 05708932999540 Catalog Number : 50495

Device Description : Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 18. Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 18. 16 in. 40 cm. Rx only.

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self-Cath - 05708932999588 Catalog Number : 50482

Device Description : Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 10. Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 10. 10 in. 25 cm.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self-Cath - 05708932999595 Catalog Number : 50481

Device Description : Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 8. Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 8. 10 in. 25 cm. Rx only.

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999670 Catalog Number : 50474

Device Description : Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 14. 16 in. Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 14. 16 in. 40 cm Rx only.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999700 Catalog Number : 50471

Device Description : Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 8. 16 in. 4 Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 8. 16 in. 40 cm Rx only.

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999717 Catalog Number : 50470

Device Description : Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 6. 16 in. 4 Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 6. 16 in. 40 cm Rx only.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999755 Catalog Number : 50466

Device Description : Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 10. 16 in Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 10. 16 in. 40 cm Rx only.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999854 Catalog Number : 50451

Device Description : Self-Cath. Urinary Catheter. Straight Tip Male. FR 10. 16 in. 40 cm Rx only.

Device Class : 2

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self Cath - 05708932999878 Catalog Number : 50443

Device Description : Self-Cath. Urinary Catheter. Luer End Pediatric. FR 10. 10 in. 25 cm Rx only.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Self-Cath - 05708932999915 Catalog Number : 50196

Device Description : Self-Cath®. Urinary Catheter. Straight Tip without connector Female. Catheter Ga Self-Cath®. Urinary Catheter. Straight Tip without connector Female. Catheter Gauge 14 FR/CH, Diameter 4.7 mm.

Device Class :

Duns Number: 305524696

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

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