Motiva® SmoothSilk® Round Ergonomix Breast Implant

Basic Information

• Brand Name: Motiva® SmoothSilk® Round Ergonomix Breast Implant
• Primary DI: 07445161010575
• Version / Model: ERSD-320
• Catalog Number: ERSD-320
• Company Name: Establishment Labs S.A.
• Labeler DUNS: 853166098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 1
• Public Version Date: 2024-10-14
• Public Version Status: New
• Public Device Record Key: ecadfc12-dbed-4994-b74a-08a835d845be

Device Description

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 320 cc

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	878.3540	3

GMDN Terms

Code	Name	Definition	Implantable	Status
64081	Silicone gel-filled breast implant, smooth-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07445161010575	GS1

Premarket Submissions

Submission Number	Supplement Number
P230005	000