Softspan Tissue Expander

Basic Information

• Brand Name: Softspan Tissue Expander
• Primary DI: 00812790029969
• Version / Model: SRE-FO-035
• Catalog Number: SRE-FO-035
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-20
• Public Version: 2
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 22a8d233-3141-4901-a41d-bc3d8635bd39

Device Description

Tissue Expander, Flat Oval, Textured Surface, Remote Port, Non-reinforced Base, 35-89 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: Labeling does not contain MRI Safety Information
• 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	00812790029969	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070303	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume: 35-89 cc