Motiva® Inflatable Balloon

Basic Information

• Brand Name: Motiva® Inflatable Balloon
• Primary DI: 07445161009586
• Version / Model: MIB-0100
• Catalog Number: MIB-0100
• Company Name: Establishment Labs S.A.
• Labeler DUNS: 853166098
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-06
• Public Version: 2
• Public Version Date: 2025-10-01
• Public Version Status: Update
• Public Device Record Key: 580441ea-d72c-40e7-a1c6-7df721a8fc07
• Distribution End Date: 2025-10-01

Device Description

Motiva® Inflatable Balloon - 10 cm base

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65237	Invasive breast implant sizer, inflatable	A manual inflatable device intended to be inserted intraoperatively into a tissue pocket surgically-created for the acceptance of a breast augmentation implant, to ascertain that sufficient space has been created for the placement of the implant. It is a balloon-like device connected to a manually-powered air pump used to expand the device; devices associated with the sizer introduction may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07445161009586	GS1