Malar Design M
MEDPOR - 9510
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Thickness: 17.0 Millimeter
- Length: 64.0 Millimeter
- Height: 19.0 Millimeter
- Thickness: 4.5 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FWP
Device Name: Prosthesis, Chin, Internal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 878.3550
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 07613252085881
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A