FOURTE Expander Fill System F-4444

GUDID 10888628043619

FOURTE Expander Fill System

Allergan, Inc.

Tissue expander injection port

• Primary Device ID: 10888628043619
• NIH Device Record Key: 3d2fa2ae-2bd4-448a-a631-ae7608d12358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOURTE Expander Fill System
• Version Model Number: F-4444
• Catalog Number: F-4444
• Company DUNS: 144796497
• Company Name: Allergan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628043619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161483

FDA Product Code

• LCJ: Expander, Skin, Inflatable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-01-14

On-Brand Devices [FOURTE Expander Fill System]

• 10888628043619: FOURTE Expander Fill System
• 10888628043602: FOURTE Expander Fill System