MENTOR MemoryGel Xtra Resterilizable Gel Sizer

Basic Information

• Brand Name: MENTOR MemoryGel Xtra Resterilizable Gel Sizer
• Primary DI: 10081317028007
• Version / Model: RSZSMHX255S
• Catalog Number: RSZ-SMHX-255S
• Company Name: MENTOR TEXAS L.P.
• Labeler DUNS: 167450993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-01
• Public Version: 1
• Public Version Date: 2021-02-09
• Public Version Status: New
• Public Device Record Key: e6f5fbb1-31e1-470a-a9d5-e1c0996045dd

Device Description

MemoryGel Xtra Moderate High (MHX) Smooth Sizer 255cc

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam 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
58856	Invasive breast implant sizer, fixed, reusable	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 is typically composed of a silicone rubber shell with a single-lumen, filled 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 reusable device intended to be resterilized between patient applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10081317028007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062421	000