Sophysa

FDA UDI

Class II (US FDA UDI)

by Sophysa SA

Identity

Trade Name: Sophysa FDA UDI
Generic Name: Peritoneal/atrial cerebrospinal fluid catheter FDA UDI
Device Name: ANTI-REFLUX ATRIAL CATHETER FDA UDI
Model / Reference: B905S-10 FDA UDI
Description: ANTI-REFLUX ATRIAL CATHETER FDA UDI

Identifiers

Primary DI / UDI-DI: 03760124130027 FDA UDI
510(k) Number: K013488 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Peritoneal/atrial cerebrospinal fluid catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Peritoneal/atrial cerebrospinal fluid catheter

Sophysa by Sophysa SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal/atrial cerebrospinal fluid catheter.

Integra® — Integra Lifesciences Corp. · Class II
AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
CODMAN® BACTISEAL® — Integra LifeSciences Production Corporation · Class II
CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
Natus® — Natus Medical Incorporated · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
Natus® — Natus Medical Incorporated · Class II

Cleared under the same submission

K013488 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Sophysa SA

Sources (1)

FDA UDI 01a7b081-26bb-4055-8f7d-cde6380371fa 34 fields · synced May 30, 2026