JUVÉDERM VOLBELLA XC

Basic Information

• Brand Name: JUVÉDERM VOLBELLA XC
• Primary DI: 10888628032446
• Version / Model: 95834
• Catalog Number: 95834
• Company Name: Allergan, Inc.
• Labeler DUNS: 144796497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 5
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f455b68a-6733-4571-aa02-953ca7d3a1a0

Device Description

Juvéderm Volbella XC 30G 2x0.55mL

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: No
• 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
LMH	Implant, Dermal, For Aesthetic Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47887	Dermal tissue reconstructive material, microbe-derived, anaesthetic	A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888628032446	GS1
Package	10888628032460	GS1	Box	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P110033	023

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			30G 2x0.55mL

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius