Motiva® Inflatable Balloon MIB-0090

GUDID 07445161009579

Motiva® Inflatable Balloon - 9 cm base

Establishment Labs S.A.

Invasive breast implant sizer, inflatable

• Primary Device ID: 07445161009579
• NIH Device Record Key: 782cec6a-52cc-4e16-9c8d-1a5a0cff6eeb
• Commercial Distribution Discontinuation: 2025-10-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motiva® Inflatable Balloon
• Version Model Number: MIB-0090
• Catalog Number: MIB-0090
• Company DUNS: 853166098
• Company Name: Establishment Labs S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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	07445161009579 [Primary]

FDA Product Code

• FZW: Expander, Surgical, Skin Graft

Sterilization

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

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

[07445161009579]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-16
• Device Publish Date: 2025-06-06

On-Brand Devices [Motiva® Inflatable Balloon]

• 07445161009586: Motiva® Inflatable Balloon - 10 cm base
• 07445161009579: Motiva® Inflatable Balloon - 9 cm base
• 07445161009494: Motiva® Inflatable Balloon - 8 cm base