Cystoject Syringe Lever SL0004

GUDID 20854913006048

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

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• Primary Device ID: 20854913006048
• NIH Device Record Key: 4663db7b-dec6-4196-82c8-0901371f21c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoject Syringe Lever
• Version Model Number: Cystoject
• Catalog Number: SL0004
• 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	00854913006044 [Primary]
GS1	20854913006048 [Package]; Contains: 00854913006044; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203321

FDA Product Code

• QBL: Piston Syringe Lever

Sterilization

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

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

[20854913006048]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-12
• Device Publish Date: 2021-01-04

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• 10854913006140 - Chilling Block: 2022-02-11
• 20854913006048 - Cystoject Syringe Lever: 2021-01-12The 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.
• 20854913006048 - Cystoject Syringe Lever: 2021-01-12 The Cystoject Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 30 mL syr
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• 00854913006037 - Uroject12 Syringe Lever: 2020-05-01 The Uroject12 Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 20 mL syr
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