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#

PMN#

Applications#

GUDID#