UROGEN PHARMA LTD

Address:9 Ha'Ta'asiya Street,Ra'anana Central,IL

Want to know more about this Organization? Request more information now!

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, Urological (KOD) (3) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (3) Catheter, Coude (EZC) (2) Piston Syringe Lever (QBL) (2) Catheter Care Tray (OHR) (1)

Premarket Exempt

No Yes

Clear

Uroject12 Syringe Lever - 00854913006037 Catalog Number : SL0002

Device Description : The Uroject12 Syringe Lever is a reusable device that is intended to assist in The Uroject12 Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 20 mL syringe during urinary tract procedures. The Uroject12 Syringe Lever body contains a syringe housing for holding a standard syringe and a dispensing mechanism that is manually operated by rotating a knob and presses the syringe piston. A clutch mechanism facilitates fast adaptation of the dispensing mechanism to the syringe piston position. The Uroject12 Syringe Lever is to be sterilized before use and cleaned after use.

Device Class :

Duns Number: 534155213

Premarket Exempt : No

Product Code : QBL

Prescription Use : Yes

Device Count : 1

Cystoject Syringe Lever - 00854913006044 Catalog Number : SL0004

Device Description : The Cystoject Syringe Lever is a reusable device that is intended to assist in The Cystoject Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 30 mL syringe during urinary tract procedures. The Cystoject Syringe Lever body contains a syringe housing for holding a standard syringe and a dispensing mechanism that is manually operated by rotating a knob and presses the syringe piston. A clutch mechanism facilitates fast adaptation of the dispensing mechanism to the syringe piston position. The Cystoject Syringe Lever is to be sterilized before use and cleaned after use.

Device Class : 2

Duns Number: 534155213

Premarket Exempt : No

Product Code : QBL

Prescription Use : Yes

Device Count : 1

7 Fr. Ureteral catheter - 10854913006058 Catalog Number :

Device Class :

Duns Number: 534155213

Premarket Exempt : No

Product Code : KOD

Prescription Use : Yes

Device Count : 1

Chilling Block - 10854913006072 Catalog Number :

Device Class :

Duns Number: 534155213

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

Chilling Block - 10854913006089 Catalog Number :

Device Class :

Duns Number: 534155213

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

Ureteral Catheter Administration Kit - 10854913006096 Catalog Number : 200006

Device Description : The Ureteral Catheter Administration Kit is designed for the convenience of the The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains:• Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL• One (1) Ureteral Catheter, 7 Fr

Device Class : 2

Duns Number: 534155213

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Urinary Catheter - 10854913006119 Catalog Number : UC0005

Device Description : The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.

Device Class : 2

Duns Number: 534155213

Premarket Exempt : No

Product Code : KOD, EZC

Prescription Use : Yes

Device Count : 1

Urinary Catheter - 10854913006126 Catalog Number : UC0006

Device Description : The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.

Device Class :

Duns Number: 534155213

Premarket Exempt : No

Product Code : KOD, EZC

Prescription Use : Yes

Device Count : 1

Chilling Block - 10854913006140 Catalog Number : UCB0002

Device Class :

Duns Number: 534155213

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

Previous 1 Next