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.
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.
IFU table
IFU table
Product Name
Product Lot Number
Corresponding IFU - PCF Revision
IFU - File
Status
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.
IFU table
Product Name
Blossom IVTE e-document
Product Lot Number
From xxxxxx
Corresponding IFU - PCF Revision
A19-046 v06
IFU - File
Status
DRAFT 1
Product Name
Blossom IVTE e-document PT
Product Lot Number
From 295104
Corresponding IFU - PCF Revision
A19-088 v06
IFU - File
Status
Archive
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