Flora™ Tissue Expander SMOOTHSILK® H-12-440

GUDID 07445161020949

Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High Height 440cc

Establishment Labs S.A.

Skin-port tissue expander

• Primary Device ID: 07445161020949
• NIH Device Record Key: 3eaa029e-141f-4177-b6b8-e002b9b62f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flora™ Tissue Expander SMOOTHSILK®
• Version Model Number: H-12-440
• Catalog Number: H-12-440
• Company DUNS: 853166098
• Company Name: Establishment Labs S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07445161020949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211676

FDA Product Code

• LCJ: Tissue Expander And Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

[07445161020949]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [Flora™ Tissue Expander SMOOTHSILK®]

• 07445161020987: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020970: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020963: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020956: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020949: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020932: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High
• 07445161020925: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Mediu
• 07445161020918: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Mediu
• 07445161020901: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Mediu
• 07445161020895: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Mediu
• 07445161020888: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Mediu
• 07445161020871: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low H
• 07445161020864: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low H
• 07445161020857: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low H
• 07445161020840: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low H