MEDPOR

Basic Information

• Brand Name: MEDPOR
• Primary DI: 07613252085959
• Version / Model: 9518
• Catalog Number: 9518
• Company Name: Stryker Leibinger GmbH & Co. KG
• Labeler DUNS: 316153956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2020-10-12
• Public Version Status: Update
• Public Device Record Key: 5c8edf46-0ad4-4d04-b74e-ff0fcc57d5fc

Device Description

Malar Extended Contoured - Large Right

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWP	PROSTHESIS, CHIN, INTERNAL	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	07613252085959	GS1

Premarket Submissions

Submission Number	Supplement Number
K922489	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Thickness: 5.0 Millimeter
Length	55.0	Millimeter
Height	27.0	Millimeter