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MENTOR CPG 313 Sterile Resterilizable Gel Breast Implant Sizer

by Mentor Medical Systems B.V. 13 variants

Ref RSZ-1156Model MENTOR Sterile Resterilizable Gel Breast Implant Sizers

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062421↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8717694a00006SD Basic UDI-DI 08717694019370UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK062421 Date10 Oct 2006IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0964-2015 FDA Class II initiated 11 Dec 2014 on shared 510(k) K062421

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

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
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000011681

Other devices from Mentor Medical Systems B.V.

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

Properties

  • 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