Phoenix Neuro

FDA UDI

Class I (US FDA UDI)

by Sophysa SA

Identity

Trade Name: Phoenix Neuro FDA UDI
Generic Name: Subcutaneous tunneller, single-use FDA UDI
Device Name: Disposable catheter passer with sheath, 45 cm length FDA UDI
Model / Reference: SP03 FDA UDI
Description: Disposable catheter passer with sheath, 45 cm length FDA UDI

Identifiers

Primary DI / UDI-DI: 03760124134803 FDA UDI
510(k) Number: K853370 FDA UDI
FDA Product Code: GYK FDA UDI
GMDN Term: Subcutaneous tunneller, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4545 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Subcutaneous tunneller, single-use

Phoenix Neuro by Sophysa SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Subcutaneous tunneller, single-use.

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PMT® CORPORATION — Pmt Corp. · Class I
Halyard — Avanos Medical, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III

Cleared under the same submission

K853370 also covers:

Phoenix Neuro — Sophysa SA
Phoenix Neuro — Sophysa SA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sophysa SA

Sources (1)

FDA UDI 52936ec5-d607-4ee5-99da-1b93e71440f5 34 fields · synced May 30, 2026