SIENTRA Chin Implant

Basic Information

• Brand Name: SIENTRA Chin Implant
• Primary DI: 00812790023271
• Version / Model: 10-055U
• Catalog Number: 10-055U
• 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: f707812d-0e9a-4518-b91b-c652cbc24826
• Distribution End Date: 2022-06-13

Device Description

Chin Implant, Solid Silicone, Smooth, 53 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
FWP	Prosthesis, Chin, Internal	General, Plastic Surgery	878.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35261	Chin prosthesis	A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812790023271	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981850	000

Device Sizes

Type	Value	Unit	Text
Length	53	Millimeter