Silicone Sizer Set for ePTFE Midfacial

Basic Information

• Brand Name: Silicone Sizer Set for ePTFE Midfacial
• Primary DI: M724ESMFSIZNS1
• Version / Model: ESMF-SIZ
• Catalog Number: ESMF-SIZ-NS
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Labeler DUNS: 784664955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-14
• Public Version: 1
• Public Version Date: 2019-06-24
• Public Version Status: New
• Public Device Record Key: 08cff5ff-55e2-4e46-9e9a-1fe1ef38e27a

Device Description

Silicone Sizer Set for ePTFE Midfacial

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZK	Implant, Malar	General, Plastic Surgery	878.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45228	Malar prosthesis	An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M724ESMFSIZNS1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141027	000