Dentsply Ih AB

Address:Piri Reisweg 23,Sevenum Limburg,NL

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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) (8)

Premarket Exempt

No Yes

Clear

LoFric® Hydro-Kit™ - 07392532250613 Catalog Number : 42510403

Device Description : Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR

Device Class : 2

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Hydro-Kit™ - 07392532250637 Catalog Number : 42512403

Device Description : Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR

Device Class : 2

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Hydro-Kit™ - 07392532250644 Catalog Number : 42514403

Device Description : Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Hydro-Kit™ - 07392532250651 Catalog Number : 42516403

Device Description : Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Hydro-Kit™ - 07392532251092 Catalog Number : 42518403

Device Description : Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Elle™ - 07392532274282 Catalog Number : 4181050

Device Description : Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR

Device Class : 2

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : No

Device Count : 1

LoFric® Elle™ - 07392532274312 Catalog Number : 4181250

Device Description : Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR

Device Class : 2

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : No

Device Count : 1

LoFric® Elle™ - 07392532274343 Catalog Number : 4181450

Device Description : Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR

Device Class : 2

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : No

Device Count : 1

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