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Sophysa

FDA UDI

Class II (US FDA UDI)

by Sophysa SA

Identity

Trade Name
Sophysa FDA UDI
Generic Name
Cerebrospinal fluid shunt valve FDA UDI
Device Name
POLARIS ADJUSTABLE VALVE, 10-140 WITH ANTICHAMBER AND SIPHONX FDA UDI
Model / Reference
SPVA-140-SX FDA UDI
Description
POLARIS ADJUSTABLE VALVE, 10-140 WITH ANTICHAMBER AND SIPHONX FDA UDI

Identifiers

Primary DI / UDI-DI
03760124131741 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid shunt valve 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

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Cerebrospinal fluid shunt valve

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

Similar devices

Also classified as Cerebrospinal fluid shunt valve.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sophysa SA

Sources (1)

  • FDA UDI e3203e08-9212-466a-94d1-63c391a94226 33 fields · synced May 30, 2026