JUVEDERM ULTRA 96206

GUDID 10888628044739

Juvéderm ULTRA 2x0.55mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived

• Primary Device ID: 10888628044739
• NIH Device Record Key: 084c4131-2e7f-44de-b222-bca31f22b4eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUVEDERM ULTRA
• Version Model Number: 96206
• Catalog Number: 96206
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8773455372
• Email: aus-psreporting@allergan.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628044739 [Package]; Contains: 10888628044746; Package: Box [2 Units]; In Commercial Distribution
GS1	10888628044746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050047

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [JUVEDERM ULTRA]

• 30888628000036: Juvederm Ultra 30G 2x0.4mL
• 30888628000029: Juvederm Ultra 30G 1x0,8mL
• 10888628044739: Juvéderm ULTRA 2x0.55mL