Phoenix Neuro (UDI SP04)

Manufactured by SOPHYSA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Phoenix Neuro (Model/Catalog Number: SP04) is a medical device manufactured by SOPHYSA. This product is indexed under FDA Product Code / Category Classification GYK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SP04
Product Code / EMDN: GYK
Device Name: Disposable catheter passer with sheath, 65 cm length
Database Sync Date: 2026-08-09 09:33:52

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Phoenix Neuro?

The registered manufacturer of record for Phoenix Neuro is SOPHYSA.

What is the Primary UDI-DI identifier for Phoenix Neuro?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SP04.

What classification code is assigned to this device?

This device is registered under product classification code GYK.

Similar Classification Devices (GYK)

Other Devices by SOPHYSA

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