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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.

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 PT

Product Lot Number

From 295104

Corresponding IFU - PCF Revision

A19-088 v06 

IFU - File

Status

Archive

Product Name

Blossom IVTE e-document PT

Product Lot Number

From 308431

Corresponding IFU - PCF Revision

A19-088 v07 

IFU - File

Status

Active 

IFU table

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - File

Status

Blossom IVTE e-document PT

From 295104

A19-088 v06 

Archive

Blossom IVTE e-document PT

From 308431

A19-088 v07 

Active 

Renuvé™ RVTE

Renuvé™ RVTE tissue expanders feature a universal self-sealing 28 mm injection port with an internal needle-stop and reinforced base, keeping puncture risk low and shell integrity high (exceeding ISO standards). Radiopaque tubing and a stainless-steel, length-adjustable connector simplify placement, while the smooth-surface expanders come sterile in five shapes—Round, Rectangular, Straight or Curved Cylindrical, and Croissant—covering 200 cc-1,100 cc volumes for face or body use.

IFU table

Product Name

Remote Valve Tissue Expanders

Product Lot Number

904663

Corresponding IFU - PCF Revision

Draft V1

IFU - File

Status

Draft V1

IFU table

Product Name

Product Lot Number

Corresponding IFU - PCF Revision

IFU - File

Status

Remote Valve Tissue Expanders

904663

Draft V1

Draft V1

Disclaimer

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