Urinary Catheter UC0005

GUDID 20854913006116

The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.

UROGEN PHARMA LTD

Single-administration urethral drainage catheter

• Primary Device ID: 20854913006116
• NIH Device Record Key: 3f44168c-0882-4cda-92a0-0197c5934d5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urinary Catheter
• Version Model Number: Urinary Catheter, 12 Fr
• Catalog Number: UC0005
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Length: 40 Centimeter
• Catheter Gauge: 12 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 12 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 12 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 12 French
• Catheter Length: 40 Centimeter
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854913006119 [Primary]
GS1	20854913006116 [Package]; Contains: 10854913006119; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211032

FDA Product Code

• KOD: Catheter, Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01

On-Brand Devices [Urinary Catheter]

• 10854913006126: The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female Luer lock hub.
• 20854913006116: The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub.