FOURTE Expander Fill System

Basic Information

• Brand Name: FOURTE Expander Fill System
• Primary DI: 10888628043602
• Version / Model: F-4444L
• Catalog Number: F-4444L
• Company Name: Allergan, Inc.
• Labeler DUNS: 144796497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 2
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: 293cff88-a106-484c-9e7a-267a2ff4c02d

Device Description

FOURTE Expander Fill System

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: No
• Has Lot/Batch Number: Yes
• 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
59036	Tissue expander injection port	A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids (e.g., saline) typically over multiple expansion sessions. It consists of an auto-sealing port for needle puncture and a tube connector for attachment to the tissue expander. It is available in a variety of designs. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888628043602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161483	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			NA