SIENTRA Tissue Expander

Basic Information

• Brand Name: SIENTRA Tissue Expander
• Primary DI: 00812790022304
• Version / Model: 800-050U3
• Catalog Number: 800-050U3
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-13
• Public Version: 2
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: dbebec44-e248-4526-9810-d355035c4530
• Distribution End Date: 2022-06-14

Device Description

Tissue Expander, Round, 3-Valves, Smooth, 50 ml

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 Unsafe
• 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
LCJ	Expander, Skin, Inflatable	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45187	Skin-port tissue expander	An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812790022304	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981852	000

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter