MENTOR CPX4, Low Height Breast Tissue Expander, Suture Tabs, Textured

Device Name

MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs

Model / Reference

MENTOR CPX4 Breast Tissue Expanders - Textured, with Suture Tabs, 354-9126NW

Primary DI / UDI-DI

10081317034435

Basic UDI-DI

0081317a0001544

EMDN Code

P900103 Breast tissue expanders

Device Class

Class III

Medical Purpose

The intended purpose of the Mentor Contour Profile Tissue Expander devices is to create a subcutaneous or submuscular pocket that will allow for the insertion of a breast implant in reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures.

EUDAMED SRN

US-PR-000013792

• MENTOR CPX4, Medium Height Breast Tissue Expander, Suture Tabs, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Low Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

• Silicone Male External Catheter

  Class I

  FDA 510(k) K913524 Active Cleared 4 Oct 1991

• MENTOR CPX4, Tall Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Low Height Breast Tissue Expander, Suture Tabs, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Medium Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

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