GC Aesthetics® Instruction For Use (IFU) and Patient Consent Form (PCF)
How to get your IFU and Patient Consent Form?
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Check on the product Label: - The Product Name - The Product Lot Number This information will allow you to find the IFU and Patient Consent Form corresponding to your product.
Find the IFU and Patient Consent Form applicable to your product in the correspondence table and check the latest version in force.
PERLE™
The novel Round Breast Implant with (r)evolutionary BioQ™ - Surface technology and highly cohesive Emunomic™ Breast Tissue Dynamic Gel. It has a unique smooth opaque surface and highly cohesive gel with an exclusive formulation in a large range of sizes and projections.¹
The Matrix™
The Matrix™ by GC Aesthetics® are anatomical textured breast implants with a firm upper pole and a firmer gel (Paragel™) with tapered edges for less visibility and palpability.¹
The Round Collection™
Available in both microtextured and smooth surface, The Round Collection™ is supported by 10-year safety data. Proven to be high quality, safe round breast implants. The Round Collection™ provides a wide range of products, including two types of gel cohesivity, and four different projections - from low to extra-high.
Product Name
Round Collection Textured e-IFU
Product Lot Number
From 3056842 Additional lot numbers : 3056181, 3056499, 3056513 to 3056518, 3056520, 3056522
Corresponding IFU - PCF Revision
904389 v08
IFU - PCF File
Status
Active
Product Name
Round Collection Smooth e-IFU
Product Lot Number
TBC by Production
Corresponding IFU - PCF Revision
904501 v01
IFU - PCF File
Status
Active
Product Name
Product Lot Number
Corresponding IFU - PCF Revision
IFU - PCF File
Status
Round Collection Textured e-IFU
From 3056842 Additional lot numbers : 3056181, 3056499, 3056513 to 3056518, 3056520, 3056522
904389 v08
Active
IMPLEO™
The IMPLEO™️ round breast implant, was designed to meet surgeon unmet needs. It features ultra-cohesive yet soft, form stable 6th generation gel.¹
Product Name
IMPLEO™ e-IFU
Product Lot Number
From 292886
Corresponding IFU - PCF Revision
A19-064 v11
IFU - PCF File
Status
Archived
Product Name
IMPLEO™ e-PCF
Product Lot Number
From 292886
Corresponding IFU - PCF Revision
A19-067 v07
IFU - PCF File
Status
Archived
Product Name
IMPLEO e-IFU
Product Lot Number
From 295539
Corresponding IFU - PCF Revision
A19-064 v12
IFU - PCF File
Status
Active
Blossom™ IVTE
Blossom™ IVTE, is the Integrated Valve Tissue Expander by GC Aesthetics®. The product is intended for temporary subcutaneous implantation and requires periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Product Name
Blossom™ IVTE e-IFU
Product Lot Number
No product manufactured with this e-IFU revision
Corresponding IFU - PCF Revision
A19-088 v05
IFU - PCF File
Status
Archived
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