FDA.reportPublic FDA data

MENTOR MemoryGel Xtra Breast Implant

Primary DI
00081317025702
Brand
MENTOR MemoryGel Xtra Breast Implant
Company
MENTOR TEXAS L.P.
Model
THPX405
Catalog number
THPX-405
Device description
SILTEX High Profile Xtra Silicone Gel-Filled Breast Implant, 405cc Textured Round Silicone
Published
2018-02-19
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
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
00081317025702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317025702000813170257020813170257020081317025702

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
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
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
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