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MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer

by Mentor Medical Systems B.V. Netherlands EUDAMED510(k)

Ref RSZ-1156Model MENTOR Sterile Resterilizable Gel Breast Implant Sizers510(k) K062421

Product code MRDEMDN P0680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8717694a00006SD Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK062421 Date10 Oct 2006ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-0964-2015 FDA Class II initiated 11 Dec 2014

    The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Device Name
MENTOR Sterile Resterilizable Gel Breast Implant Sizers
Model / Reference
MENTOR Sterile Resterilizable Gel Breast Implant Sizers, RSZ-1156
Primary DI / UDI-DI
08717694019370
Basic UDI-DI
8717694a00006SD
Direct Marketing DI
08717694019370
EMDN Code
P0680 Breast implants - accessories
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000011681
FDA applicant
Mentor Corporation

Other devices from Mentor Medical Systems B.V.

See all devices from Mentor Medical Systems B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 8c611843-a8be-479e-8ba3-a5bdcd9ac55c 85 fields · synced 22 Oct 2026
  • FDA 510(k) K062421 1 fields · synced 18 May 2026