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MENTOR Smooth Round High Profile Saline Breast Implant

by Mentor 15 variants

Ref 350-3330Model MENTOR Saline-Filled Breast Implants

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0081317a000043X Basic UDI-DI 00081317001645UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00081317001645 UDI-DI Date17 Sep 2014ListedStatusListed GUDID: in commercial distribution

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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0367-2022 FDA Class II initiated 30 Sep 2021

    Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

    • Terminated Z-2070-2017 FDA Class II initiated 27 Mar 2017

    Missing Dome Pack accessory.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MENTOR Smooth Round High Profile Saline Breast Implant EUDAMED
MENTOR Smooth Round High Profile GUDID
Generic Name
Saline-filled breast implant, unstructured, smooth-surface
Device Name
MENTOR Saline-Filled Breast Implants
Model / Ref / Catalog
MENTOR Saline-Filled Breast Implants, 350-3330, 3503330
Primary DI / UDI-DI
00081317001645
Basic UDI-DI
0081317a000043X
PMA Number
FDA Product Code
FWM
EMDN Code
P0601010101 Breast implants, round, saline, with smooth surface
GMDN Term
Saline-filled breast implant, unstructured, smooth-surface
Device Class
Class III
Regulation Number
878.3530
Medical Purpose
The intended purpose of the Mentor Saline-Filled Breast Implants is to replace missing breast tissue or to enhance a breast in females undergoing breast augmentation (non-medical) or breast reconstruction (medical purpose)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MENTOR Saline-Filled Breast Implants
350-3330
GUDID
3503330
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-PR-000013792

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No