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® - 07392532135248 Catalog Number : 4030840

Device Description : Single Use Urinary Catheter LoFric Nelaton 8" 08FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135255 Catalog Number : 4031040

Device Description : Single Use Urinary Catheter LoFric Nelaton 8" 10FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135262 Catalog Number : 4031640

Device Description : Single Use Urinary Catheter LoFric Nelaton 8" 16FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135279 Catalog Number : 4031840

Device Description : Single Use Urinary Catheter LoFric Nelaton 8" 18FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135286 Catalog Number : 4040840

Device Description : Single Use Urinary Catheter LoFric Nelaton 6" 08FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135293 Catalog Number : 4041040

Device Description : Single Use Urinary Catheter LoFric Nelaton 6" 10FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135309 Catalog Number : 4041240

Device Description : Single Use Urinary Catheter LoFric Nelaton 6" 12FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

LoFric® - 07392532135316 Catalog Number : 4041440

Device Description : Single Use Urinary Catheter LoFric Nelaton 6" 14FR

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

Dila-Cath Nelaton 40cm CH18 - 07392532135323 Catalog Number : 4061800

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

LoFric® Primo™ - 07392532135422 Catalog Number : 4110640

Device Description : Single Use Urinary Catheter LoFric Primo Nelaton 8" 06FR Paediatric

Device Class :

Duns Number: 354059073

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

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