JUVEDERM ULTRA XC 96207

GUDID 10888628044753

Juvéderm ULTRA XC 2x0.55mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 10888628044753
• NIH Device Record Key: 8371cb1c-aec6-4658-8dba-478cd30e461e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUVEDERM ULTRA XC
• Version Model Number: 96207
• Catalog Number: 96207
• 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: true
• 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	10888628044753 [Package]; Contains: 10888628044760; Package: Box [2 Units]; In Commercial Distribution
GS1	10888628044760 [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 XC]

• 30888628000081: Juvederm Ultra XC 30G 2x1.0mL
• 30888628000074: Juvederm Ultra XC 30G 2x0.4mL
• 30888628000067: Juvederm Ultra XC 30G 1x0,8mL
• 10888628044753: Juvéderm ULTRA XC 2x0.55mL