pORTAL® EXT Extension Wire

GUDID 05391530910057

The pORTAL extension wire is intended to interface with pORTAL Neuro Wire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL Neuro Wire. This enables the usable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Neuro Wire.

PHENOX LIMITED

Peripheral vascular guidewire, manual

• Primary Device ID: 05391530910057
• NIH Device Record Key: b8bf4037-075f-4167-91ce-b3e84e955836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pORTAL® EXT Extension Wire
• Version Model Number: PORT-14-115-1-EX
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05391530910057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191687

FDA Product Code

• MOF: Guide, Wire, Catheter, Neurovasculature

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: 2020-02-14
• Device Publish Date: 2020-02-06

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