Codman Hakim Siphonguard

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name: CODMAN HAKIM SIPHONGUARD FDA UDI
Generic Name: Ventriculoperitoneal shunt FDA UDI
Device Name: CODMAN HAKIM Programmable In-Line Valve with SIPHONGUARD Device Unitized 14cm Ventricular Catheter and Unitized 120cm Peritoneal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Stylet, Right Angle Adapter, Introducer, Priming Adapter and Information Manual FDA UDI
Model / Reference: NS0543 FDA UDI
Description: CODMAN HAKIM Programmable In-Line Valve with SIPHONGUARD Device Unitized 14cm Ventricular Catheter and Unitized 120cm Peritoneal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Stylet, Right Angle Adapter, Introducer, Priming Adapter and Information Manual FDA UDI

Identifiers

Catalog Number: NS0543 FDA UDI
Primary DI / UDI-DI: 10886704045779 FDA UDI
510(k) Number: K020667 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Ventriculoperitoneal shunt FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: Not 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Codman Hakim Siphonguard by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K020667 also covers:

CODMAN® HAKIM® — Integra LifeSciences Production Corporation

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: Cerenovus, Inc.

Sources (1)

FDA UDI 6e5f2496-8636-4a5b-a4b4-ca59f78bcf90 37 fields · synced Jun 8, 2026