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Sophysa

FDA UDI

Class II (US FDA UDI)

by Sophysa SA

Identity

Trade Name
Sophysa FDA UDI
Generic Name
Intracerebral infusion/drainage catheter, long-term FDA UDI
Device Name
RIGHT ANGLE VENTRIC.CATH.RESER/PECT.11CM FDA UDI
Model / Reference
PLO11 FDA UDI
Description
RIGHT ANGLE VENTRIC.CATH.RESER/PECT.11CM FDA UDI

Identifiers

Primary DI / UDI-DI
03760124130362 FDA UDI
510(k) Number
K013488 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Intracerebral infusion/drainage catheter, long-term 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 Safe FDA UDI

Category: Intracerebral infusion/drainage catheter, long-term

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

Similar devices

Also classified as Intracerebral infusion/drainage catheter, long-term.

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 cbef0cd9-bf1d-4766-b27a-14feb13a2c03 34 fields · synced May 30, 2026