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Found 12 results
510(k) Data Aggregation
K Number
K243271Device Name
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
Manufacturer
Mentor Worldwide, LLC
Date Cleared
2025-01-13
(89 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
Device Description
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.
The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
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K Number
K241552Device Name
MENTOR MemoryGel Enhance Single Use Gel Sizer
Manufacturer
Mentor Worldwide LLC
Date Cleared
2024-09-06
(98 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implanted.
Device Description
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast Implant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
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K Number
K203229Device Name
NATRELLE INSPIRA Single Use Sizers for Gel Implants
Manufacturer
Allergan
Date Cleared
2021-06-02
(212 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Device Description
NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.
NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.
NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.
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K Number
K200706Device Name
Sientra OPUS Silicone Gel Breast Implant Sizer
Manufacturer
Sientra, Inc
Date Cleared
2020-11-16
(243 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.
Device Description
The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.
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K Number
K183163Device Name
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
Manufacturer
Motiva USA, LLC
Date Cleared
2019-02-05
(82 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are temporary intraoperative placement devices used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use.
Device Description
Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are sizing devices designed for temporary intraoperative placement, to assist in determining the desired breast implant volume and shape for each patient prior to implantation of a Motiva Implant Matrix® silicone breast implant. They are used during breast augmentation or reconstruction procedures.
The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are constructed with a low diffusion shell featuring a barrier layer between various layers of silicone elastomer to minimize gel diffusion; a patch, and cohesive restricted medical grade silicone gel, which is aimed for intraoperative temporary implantation only. The filling gel is tinted with pigments, in order for the Round Sizers to be clearly differentiated from the long term implantable devices.
The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® have been designed to match every Motiva Implant Matrix® silicone breast implant reference, and are therefore available in the same range of bases or diameters, projections and volumes as the long term implants.
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K Number
K151055Device Name
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
Manufacturer
MENTOR WORLDWIDE LLC
Date Cleared
2015-05-20
(30 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
Device Description
The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.
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K Number
K131853Device Name
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
Manufacturer
MENTOR WORLDWIDE LLC
Date Cleared
2013-07-17
(26 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
Device Description
The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided non-sterile to be sterilized prior to initial use and then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.
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K Number
K062421Device Name
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
Manufacturer
MENTOR CORPORATION
Date Cleared
2006-10-10
(53 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
Device Description
The Mentor Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.
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K Number
K010709Device Name
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
Manufacturer
MENTOR CORP.
Date Cleared
2001-04-23
(45 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984106Device Name
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
Manufacturer
SPECIALTY SURGICAL PRODUCTS, INC.
Date Cleared
1999-02-12
(87 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Product Code :
MRD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.
Device Description
Not Found
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