FDA.reportPublic FDA data

MENTOR Smooth Round SPECTRUM

Primary DI
00081317002000
Brand
MENTOR Smooth Round SPECTRUM
Company
MENTOR TEXAS L.P.
Model
3501460
Catalog number
350-1460
Device description
Post Operatively Adjustable Saline Breast Implant, 375cc Smooth Round Saline
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00081317002000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317002000000813170020000813170020000081317002000

GMDN Terms#

Term, Definition table
TermDefinition
Saline-filled breast implant, unstructuredA sterile 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 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, shell surface, 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
10081317028779MENTOR 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