Motiva Implant Matrix

Basic Information

• Brand Name: Motiva Implant Matrix
• Primary DI: 07445161014566
• Version / Model: SZD-285
• Catalog Number: SZD-285
• Company Name: Establishment Labs S.A.
• Labeler DUNS: 853166098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-25
• Public Version: 1
• Public Version Date: 2021-11-02
• Public Version Status: New
• Public Device Record Key: e1c3080c-1369-428d-9b39-81c97c2baf55

Device Description

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 285 cc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRD	Sizer, Mammary, Breast Implant Volume	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34178	Invasive breast implant sizer, fixed, single-use	A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07445161014566	GS1