FDA.reportPublic FDA data

MENTOR MemoryGel Xtra Breast Implant

Primary DI
00081317025535
Brand
MENTOR MemoryGel Xtra Breast Implant
Company
MENTOR TEXAS L.P.
Model
TMPX525
Catalog number
TMPX525
Device description
SILTEX Moderate Plus Profile Xtra Silicone Gel-Filled Breast Implant, 525cc
Published
2018-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTRProsthesis, breast, noninflatable, internal, silicone gel-filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledGeneral, Plastic Surgery3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081317025535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317025535000813170255350813170255350081317025535

GMDN Terms#

Term, Definition table
TermDefinition
Silicone gel-filled breast implantA sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel. The implant 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10081317031052MENTOR MemoryGel Enhance Breast ImplantSUHE1030SUHE-10302025-04-01
10081317031069MENTOR MemoryGel Enhance Breast ImplantSUHE1135SUHE-11352025-04-01
10081317031076MENTOR MemoryGel Enhance Breast ImplantSUHE1240SUHE-12402025-04-01
10081317031083MENTOR MemoryGel Enhance Breast ImplantSUHE1340SUHE-13402025-04-01
10081317031090MENTOR MemoryGel Enhance Breast ImplantSUHE1445SUHE-14452025-04-01
10081317031106MENTOR MemoryGel Enhance Breast ImplantSUHE930SUHE-9302025-04-01
10081317032684MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE1030SZ-UHE-10302025-04-01
10081317032691MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE1135SZ-UHE-11352025-04-01
10081317032707MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE1240SZ-UHE-12402025-04-01
10081317032714MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE1340SZ-UHE-13402025-04-01
10081317032721MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE1445SZ-UHE-14452025-04-01
10081317032738MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileSZUHE930SZ-UHE-9302025-04-01
10081317032332MENTOR CPX4 PLUS Enhance, Smooth, Tall HeightSCPX15THESCPX-15TH-E2025-03-26
10081317028670MENTOR Smooth Round Moderate Plus Profile3502225D350-2225D2025-03-17
10081317028687MENTOR Smooth Round Moderate Plus Profile3502250D350-2250D2025-03-17
10081317028694MENTOR Smooth Round Moderate Plus Profile3502275D350-2275D2025-03-17
10081317028700MENTOR Smooth Round Moderate Plus Profile3502300D350-2300D2025-03-17
10081317028717MENTOR Smooth Round Moderate Plus Profile3502325D350-2325D2025-03-17
10081317028724MENTOR Smooth Round Moderate Plus Profile3502350D350-2350D2025-03-17
10081317028731MENTOR Smooth Round Moderate Plus Profile3502375D350-2375D2025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161001702Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001719Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001726Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001733Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001740Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001757Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001764Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001849Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001856Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001863Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001870Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001887Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001894Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001900Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001917Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001924Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001931Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001948Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001955Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001962Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001979Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002051Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002068Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002075Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002082Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002099Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002105Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002112Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002129Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002136Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04