FDA.reportPublic FDA data

UROGEN PHARMA LTD.

Matched from indexed company URL: UroGen Pharma Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30130241913013024191UROGEN PHARMA LTD.1N2026-01-019 Ha'Ta'asiya Street Ra'anana Central IL 4365007

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10854913006201Intravesical Administration Kit - The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary Catheter, 16 Fr (Coude Olive Tip) with Luer lock, one (1) Urinary Catheter, 16 Fr (Straight Tip) with Luer lock, one (1) Luer lock Syringe, 5 mL, four (4) Luer lock Syringe, 20 mL, six (6) CSTD Syringe Adaptors, two (2) CSTD Catheter Luer lock Adaptors, one (1) Polybag1-855-987-6436urogen.safety@fortrea.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2119781572687993K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD2021-11-19
2119781044191664K180354UroGen Ureteral CatheterKOD2018-10-30
2119781265879449K180345Uroject12 Syringe LeverQBL2018-10-17
2119781236808138
2119781784322704

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KOD22021-11-19
QBL12018-10-17

NDC#

JELMYTO

UroGen Pharma, Inc.

mitomycin

PMN#

Applications#

GUDID#

Intravesical Administration Kit - The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary Catheter, 16 Fr (Coude Olive Tip) with Luer lock, one (1) Urinary Catheter, 16 Fr (Straight Tip) with Luer lock, one (1) Luer lock Syringe, 5 mL, four (4) Luer lock Syringe, 20 mL, six (6) CSTD Syringe Adaptors, two (2) CSTD Catheter Luer lock Adaptors, one (1) Polybag

UROGEN PHARMA LTD

2026-03-15

Cystoject Syringe Lever - 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.

UROGEN PHARMA LTD

2021-01-04

Intravesical Administration Kit - The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary Catheter, 16 Fr (Coude Tip) with Luer lock, one (1) Urinary Catheter, 16 Fr (Straight Tip) with Luer lock, one (1) Luer lock Syringe, 5 mL, four (4) Luer lock Syringe, 20 mL, six (6) CSTD Syringe Adaptors, two (2) CSTD Catheter Luer lock Adaptors, one (1) Polybag

UROGEN PHARMA LTD

2025-06-16

Cystoject Syringe Lever - 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.

UROGEN PHARMA LTD

2021-01-04

Uroject12 Syringe Lever - 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.

UROGEN PHARMA LTD

2019-02-11