OPUS Silicone Gel Breast Implant

Basic Information

• Brand Name: OPUS Silicone Gel Breast Implant
• Primary DI: 00819409022090
• Version / Model: 10621-445XP
• Catalog Number: 10621-445XP
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-15
• Public Version: 2
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 5682ae60-b0f3-45ac-b60e-bfa07c037eea

Device Description

Silicone Gel Breast Implant, Smooth Round, Xtra High Projection, 445 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: Yes
• 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
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	878.3540	3

GMDN Terms

Code	Name	Definition	Implantable	Status
64081	Silicone gel-filled breast implant, smooth-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819409022090	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P070004	015

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume: 445 cc