Promepla

Address:9 AVENUE PRINCE ALBERT II,MONACO Monaco-Ville,MC

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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, Ureteral, Gastro-Urology (EYB) (4) Dislodger, Stone, Basket, Ureteral, Metal (FFL) (4) Catheter, Irrigation (GBX) (2)

Premarket Exempt

No Yes

Clear

OlyCath Straight 0 Eye 5 French - 03700512968023 Catalog Number : OLCAS05

Device Description : Ureteral catheter, L. 80cm straight open, without eye, 05 CH/Fr

Device Class :

Duns Number: 401020409

Premarket Exempt : No

Product Code : EYB

Prescription Use : Yes

Device Count : 1

OlyCath Straight 0 Eye 6 French - 03700512968030 Catalog Number : OLCAS06

Device Description : Ureteral catheter, L. 80cm straight open, without eye, 06 CH/Fr

Device Class :

Duns Number: 401020409

Premarket Exempt : No

Product Code : EYB

Prescription Use : Yes

Device Count : 1

OlyCath Straight 0 Eye 7 French - 03700512968047 Catalog Number : OLCAS207

Device Description : Ureteral catheter, L. 80cm straight open, without eye, 07 CH/Fr

Device Class :

Duns Number: 401020409

Premarket Exempt : No

Product Code : EYB

Prescription Use : Yes

Device Count : 1

OlyCath Straight 0 Eye 8 French - 03700512968054 Catalog Number : OLCAS08

Device Description : Ureteral catheter, L. 80cm straight open, without eye, 08 CH/Fr

Device Class :

Duns Number: 401020409

Premarket Exempt : No

Product Code : EYB

Prescription Use : Yes

Device Count : 1

Mitt Basket - 03700512968184 Catalog Number : MITB1900

Device Description : Ngage-like open mouth basket

Device Class : 2

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

OlyPercX PCNL Basket - 03700512968191 Catalog Number : RFPERKX

Device Description : for Rocamed Laser fiber max 272µm

Device Class :

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Six Wire Basket - 03700512968207 Catalog Number : SIXW1700

Device Description : Kobot 6 Wire Basket

Device Class :

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Tipless Basket - 03700512968214 Catalog Number : TIPL1300

Device Description : 1.3 Fr Basket

Device Class :

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Tuohy Borst Simple - 03700512968221 Catalog Number : RTBS

Device Description : Tuohy Borst

Device Class :

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tuohy Borst with Y Luer Lock - 03700512968238 Catalog Number : RTBY

Device Description : Tuohy Borst

Device Class :

Duns Number: 401020409

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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