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MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer

by Mentor United States EUDAMEDGUDID

Ref 351-2350SZModel MENTOR Saline Breast Implant Sizers

Product code MRDEMDN P0680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10081317029578 UDI-DIDate15 Sep 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0081317a0000643 Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-2591-2014 FDA Class II initiated 2 Jul 2014

    The device labeling is stamped with 330cc and the device is actually 380cc device.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Invasive breast implant sizer, fixed, single-use
Device Name
MENTOR Saline Breast Implant Sizers
Model / Ref / Catalog
MENTOR Saline Breast Implant Sizers, 351-2350SZ
Primary DI / UDI-DI
10081317029578
Basic UDI-DI
0081317a0000643
510(k) Number
FDA Product Code
MRD
EMDN Code
P0680 Breast implants - accessories
GMDN Term
Invasive breast implant sizer, fixed, single-use
Device Class
Class IIa EUDAMED
U GUDID
Medical Purpose
The intended purpose of Mentor Breast Implant Sizers is for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
U
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-PR-000013792

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
Other properties (7)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fee22e2b-5a3f-4dcc-934d-52586d1f35cb 61 fields · synced 23 Oct 2026
  • FDA UDI 2ab9c7e7-1901-439e-955b-7f7f5da5ac4c 36 fields · synced 23 Oct 2026