Uroject12 Syringe Lever SL0002

GUDID 00854913006037

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

Syringe dispensing screw-press

• Primary Device ID: 00854913006037
• NIH Device Record Key: 666c59d2-4c3b-4eb1-a9a4-9f4c0dbbb85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uroject12 Syringe Lever
• Version Model Number: Uroject12
• Catalog Number: SL0002
• Company DUNS: 534155213
• Company Name: UROGEN PHARMA LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854913006037 [Primary]
GS1	20854913006031 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• QBL: Piston Syringe Lever

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00854913006037]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-01
• Device Publish Date: 2019-02-11

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