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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

Product Name

PERLE™ e-PCF

Product Lot Number

TBC by Production

Corresponding IFU - PCF Revision

A19-095 v01

IFU - PCF File

Status

Active

Product Name

PERLE™ e-IFU

Product Lot Number

TBC by Production

Corresponding IFU - PCF Revision

A19-094 v04

IFU - PCF File

Status

Active

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - PCF File

Status

PERLE™ e-PCF

TBC by Production

A19-095 v01

Active

PERLE™ e-IFU

TBC by Production

A19-094 v04

Active

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

Product Name

The Matrix e-IFU

Product Lot Number

TBC by Production

Corresponding IFU - PCF Revision

904371 v07

IFU - PCF File

Status

Active

Product Name

The Matrix e-PCF

Product Lot Number

TBC by Production

Corresponding IFU - PCF Revision

904212 v10

IFU - PCF File

Status

Active

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - PCF File

Status

The Matrix e-IFU

TBC by Production

904371 v07

Active

The Matrix e-PCF

TBC by Production

904212 v10

Active

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

Round Collection e-PCF

Product Lot Number

From 3056842 Additional lot numbers : 3056181, 3056499, 3056513 to 3056518, 3056520, 3056522

Corresponding IFU - PCF Revision

904212 v10

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

Round Collection Smooth e-IFU

TBC by Production

904501 v01

Active

Round Collection e-PCF

From 3056842 Additional lot numbers : 3056181, 3056499, 3056513 to 3056518, 3056520, 3056522

904212 v10

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

Product Name

IMPLEO e-PCF

Product Lot Number

From 295539

Corresponding IFU - PCF Revision

A19-067 v08

IFU - PCF File

Status

Active

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - PCF File

Status

IMPLEO™ e-IFU

From 292886

A19-064 v11

Archived

IMPLEO™ e-PCF

From 292886

A19-067 v07

Archived

IMPLEO e-IFU

From 295539

A19-064 v12

Active

IMPLEO e-PCF

From 295539

A19-067 v08

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

Product Name

Blossom IVTE e-IFU

Product Lot Number

From 295104

Corresponding IFU - PCF Revision

A19-088 v06

IFU - PCF File

Status

Active

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - PCF File

Status

Blossom™ IVTE e-IFU

No product manufactured with this e-IFU revision

A19-088 v05

Archived

Blossom IVTE e-IFU

From 295104

A19-088 v06

Active

Disclaimer

The information currently available on the site is solely intended for products shipped to Brazil.
The information presented here is not intended or implied to be a substitute for professional medical advice, diagnosis, or treatment. All content and information contained on or available through this website is for general information purposes only. You are encouraged to confirm any information obtained from or through this content with other sources and review all information regarding any medical condition or treatment with your physician.