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Sophysa

FDA UDI

Class II (US FDA UDI)

by Sophysa SA

Identity

Trade Name
Sophysa FDA UDI
Generic Name
Ventriculo-peritoneal/atrial shunt FDA UDI
Device Name
SOPHY SM8A KIT PREATTACHED/BO19-10 FDA UDI
Model / Reference
SM8A-2010 FDA UDI
Description
SOPHY SM8A KIT PREATTACHED/BO19-10 FDA UDI

Identifiers

Primary DI / UDI-DI
03760124131222 FDA UDI
510(k) Number
K013488 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Ventriculo-peritoneal/atrial shunt 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Ventriculo-peritoneal/atrial shunt

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

Similar devices

Also classified as Ventriculo-peritoneal/atrial shunt.

Cleared under the same submission

K013488 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sophysa SA

Sources (1)

  • FDA UDI 8d958909-0dae-4b19-af4b-d36dc82ddb25 34 fields · synced May 30, 2026