FDA.reportPublic FDA data

MENTOR Smooth Round Moderate Plus Profile

Primary DI
10081317028779
Brand
MENTOR Smooth Round Moderate Plus Profile
Company
MENTOR TEXAS L.P.
Model
3502175D
Catalog number
350-2175D
Device description
Saline Breast Implant, 175cc Smooth Round Saline
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWMProsthesis, breast, inflatable, internal, saline

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWMProsthesis, Breast, Inflatable, Internal, SalineGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990075019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990075019MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESMentor Worldwide, LLC2000-05-10FWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10081317028779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008131702877910081317028779

GMDN Terms#

Term, Definition table
TermDefinition
Saline-filled breast implant, unstructured, smooth-surface An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume and shell thickness.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-5731xx@xx.xx

Regulatory Flags#

DUNS number
167450993
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081317023487Coleman Luer Lock CapCOL-LLCAPCOL-LLCAP2016-09-14
00081317027171MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB130SRSZ-MPB-130S2022-02-15
00081317027188MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB160SRSZ-MPB-160S2022-02-15
00081317027195MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB185SRSZ-MPB-185S2022-02-15
00081317027201MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB210SRSZ-MPB-210S2022-02-15
00081317027218MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB235SRSZ-MPB-235S2022-02-15
00081317027225MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB265SRSZ-MPB-265S2022-02-15
00081317027232MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB290SRSZ-MPB-290S2022-02-15
00081317027249MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB320SRSZ-MPB-320S2022-02-15
00081317027256MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB340SRSZ-MPB-340S2022-02-15
00081317027263MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB390SRSZ-MPB-390S2022-02-15
00081317027270MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB430SRSZ-MPB-430S2022-02-15
00081317027287MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB450SRSZ-MPB-450S2022-02-15
00081317027294MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB480SRSZ-MPB-480S2022-02-15
00081317027300MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB530SRSZ-MPB-530S2022-02-15
00081317027317MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB545SRSZ-MPB-545S2022-02-15
00081317027324MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB590SRSZ-MPB-590S2022-02-15
00081317027331MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB630SRSZ-MPB-630S2022-02-15
00081317027348MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB675SRSZ-MPB-675S2022-02-15
00081317027355MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB730SRSZ-MPB-730S2022-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10081317028670MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028687MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028694MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028700MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028717MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028724MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028731MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028748MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028755MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028762MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028786MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028793MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028809MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028816MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028823MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028830MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028847MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028854MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028861MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028939MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028946MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028953MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028960MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028977MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028984MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028991MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029004MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029011MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029028MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029035MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17