SIENTRA Pectoral Implant

Basic Information

• Brand Name: SIENTRA Pectoral Implant
• Primary DI: 00812790023141
• Version / Model: 20132-160DU
• Catalog Number: 20132-160DU
• 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: 7
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 3798c9f1-1482-4195-b75d-66feb26f8c3a
• Distribution End Date: 2022-06-13

Device Description

Pectoral Implant, Silicone Elastomer, Textured, Right, 230 cc

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
MIB	Elastomer, Silicone Block	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812790023141	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042054	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume: 230 cc