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) (9) SOUND, URETHRAL, METAL OR PLASTIC (FBX) (1)

Premarket Exempt

No Yes

Clear

LoFric® Primo™ - 07392532131608 Catalog Number : 4151440

Device Description : Single Use Urinary Catheter LoFric Primo Coudé 16" 14FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131615 Catalog Number : 4151240

Device Description : Single Use Urinary Catheter LoFric Primo Coudé 16" 12FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131622 Catalog Number : 4151040

Device Description : Single Use Urinary Catheter LoFric Primo Coudé 16" 10FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131639 Catalog Number : 4101840

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 18FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131646 Catalog Number : 4101640

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 16FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131653 Catalog Number : 4101440

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 14FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131660 Catalog Number : 4101240

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 12FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131677 Catalog Number : 4101040

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 10FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® Primo™ - 07392532131684 Catalog Number : 4100840

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 16" 08FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Dila-Cath Nelaton 40cm CH16 - 07392532131707 Catalog Number : 4061600

Device Description : Urinary catheter for intermittent dilatation

Device Class : 1

Duns Number: 354059073

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

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