← Back to catalogue

MENTOR CPX4 PLUS, Smooth, Medium Height

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name
MENTOR CPX4 PLUS, Smooth, Medium Height FDA UDI
Generic Name
Skin-port tissue expander FDA UDI
Device Name
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650CC FDA UDI
Model / Reference
SCPX146MH FDA UDI
Description
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650CC FDA UDI

Identifiers

Catalog Number
SCPX-146MH FDA UDI
Primary DI / UDI-DI
10081317028397 FDA UDI
510(k) Number
K182335 FDA UDI
FDA Product Code
LCJ FDA UDI
GMDN Term
Skin-port tissue expander FDA UDI

Classification

Device Class
U 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Skin-port tissue expander

MENTOR CPX4 PLUS, Smooth, Medium Height by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-port tissue expander.

Cleared under the same submission

K182335 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mentor Texas LP

Sources (1)

  • FDA UDI 1f7935a7-9a95-4c21-9704-0a67991ffcfe 36 fields · synced May 29, 2026