Identity
- Trade Name
- Uroject12 Syringe Lever FDA UDI
- Generic Name
- Syringe dispensing screw-press FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Uroject12 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SL0002 FDA UDI
- Primary DI / UDI-DI
- 00854913006037 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
Uroject12 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.
- Cystoject Syringe Lever — Urogen Pharma, Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Urogen Pharma, Ltd.
Sources (1)
- FDA UDI 666c59d2-4c3b-4eb1-a9a4-9f4c0dbbb85f 34 fields · synced May 31, 2026