SIENTRA Malar Implant

Basic Information

• Brand Name: SIENTRA Malar Implant
• Primary DI: 00812790023325
• Version / Model: 25-40EU
• Catalog Number: 25-40EU
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 6
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 79000a9f-9477-4fdb-b9a8-cdba8abc6c88
• Distribution End Date: 2022-06-13

Device Description

Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 40 mm

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
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	00812790023325	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981835	000

Device Sizes

Type	Value	Unit	Text
Length	40	Millimeter