pORTAL® Steerable Hydrophilic Guidewire

GUDID 05391530910040

The pORTAL Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guidewire provides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid the successful use of the device.

PHENOX LIMITED

Peripheral vascular guidewire, manual

• Primary Device ID: 05391530910040
• NIH Device Record Key: 58040093-d78f-43f6-85e8-66d7adc31313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pORTAL® Steerable Hydrophilic Guidewire
• Version Model Number: PORT-14-200-1
• 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	05391530910040 [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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