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Cystoject Syringe Lever

FDA UDI

Class II (US FDA UDI)

by Urogen Pharma, Ltd.

Identity

Trade Name
Cystoject Syringe Lever FDA UDI
Generic Name
Syringe dispensing screw-press FDA UDI
Device Name
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. FDA UDI
Model / Reference
Cystoject FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
SL0004 FDA UDI
Primary DI / UDI-DI
00854913006044 FDA UDI
510(k) Number
K203321 FDA UDI
FDA Product Code
QBL FDA UDI
GMDN Term
Syringe dispensing screw-press FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Syringe dispensing screw-press

Cystoject Syringe Lever by Urogen Pharma, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Syringe dispensing screw-press.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urogen Pharma, Ltd.

Sources (1)

  • FDA UDI 4663db7b-dec6-4196-82c8-0901371f21c5 35 fields · synced May 30, 2026