pNOVUS 21 Microcatheter (160cm)

GUDID 05391530910392

The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures.

PHENOX LIMITED

Vascular microcatheter

• Primary Device ID: 05391530910392
• NIH Device Record Key: 2ffda539-c4aa-498c-8dd3-fd8876dc7192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pNOVUS 21 Microcatheter (160cm)
• Version Model Number: PNOV-21-160
• Company DUNS: 985621869
• Company Name: PHENOX LIMITED
• 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: false
• 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: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter
• Catheter Length: 160 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530910392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242420

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2024-12-10
• Device Publish Date: 2024-12-02

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