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MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer

by Mentor United States EUDAMEDGUDID

Ref 351-175SZD, 351-225SZD, 351-375SZ, 351-475SZD, 351-425SZ, 351-275SZD, 351-225SZ, 351-125SZD, 351-425SZD, 351-325SZModel MENTOR Saline Breast Implant Sizers Product code MRDEMDN P0680

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10081317029943 UDI-DIDate15 Sep 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0081317a000033V 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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, 351-175SZD, 351-225SZD, 351-375SZ, 351-475SZD, 351-425SZ, 351-275SZD, 351-225SZ, 351-125SZD, 351-425SZD, 351-325SZ
Primary DI / UDI-DI
10081317029943, 10081317029974, 10081317030024, 10081317030079, 10081317030055, 10081317029998, 10081317029967, 10081317029936, 10081317030048, 10081317030000
Basic UDI-DI
0081317a000033V, 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
Market of Registration
Belgium
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
Yes
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-MF-000013525
Authorised representative
MENTOR MEDICAL SYSTEMS B.V. NL-AR-000012734

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDGUDIDNoEUDAMED
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number NoGUDIDYesGUDID
  • Expiration Date
Other properties (17)
  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No

Sources (20)

  • EUDAMED 134108d0-e846-421f-8020-b320b875a4c3 61 fields · synced 22 Oct 2026
  • EUDAMED 10081317029974|0081317A000033V 61 fields · synced 16 May 2026
  • EUDAMED 10081317030024|0081317A0000643 61 fields · synced 17 May 2026
  • EUDAMED 10081317030079|0081317A000033V 61 fields · synced 17 May 2026
  • EUDAMED 10081317030055|0081317A0000643 61 fields · synced 18 May 2026
  • EUDAMED 10081317029998|0081317A000033V 61 fields · synced 18 May 2026
  • EUDAMED 10081317029967|0081317A0000643 61 fields · synced 18 May 2026
  • EUDAMED 10081317029936|0081317A000033V 61 fields · synced 18 May 2026
  • EUDAMED 10081317030048|0081317A000033V 61 fields · synced 19 May 2026
  • EUDAMED 10081317030000|0081317A0000643 61 fields · synced 19 May 2026
  • FDA UDI 90ef1eac-c775-4acc-ab99-c36d1e2504a3 36 fields · synced 23 Oct 2026
  • FDA UDI e245b71c-9ff1-4f76-a16f-dba2213f6498 36 fields · synced 23 Oct 2026
  • FDA UDI 0f3a9912-5f80-4a0d-992b-8038367d1ec4 36 fields · synced 23 Oct 2026
  • FDA UDI dc797971-c58e-4af6-acf2-31ffe3142929 36 fields · synced 23 Oct 2026
  • FDA UDI 0406f83b-ae75-4dff-8bb1-547978a8e4e6 36 fields · synced 23 Oct 2026
  • FDA UDI 957b5c05-4edc-4081-9f94-8f4989e6d057 36 fields · synced 23 Oct 2026
  • FDA UDI 68fcd2cf-f8eb-4f24-bd05-7339dbd5ef2b 36 fields · synced 23 Oct 2026
  • FDA UDI 9c5a14dc-906d-4936-8f7f-687c6c805a26 36 fields · synced 23 Oct 2026
  • FDA UDI 433c1db9-316e-48cc-806c-091c045ea450 36 fields · synced 23 Oct 2026
  • FDA UDI eeafdadd-5a3e-446f-a472-a1d0e53c40b7 36 fields · synced 23 Oct 2026