JUVÉDERM VOLBELLA XC 95834 

GUDID 10888628032446

Juvéderm Volbella XC 30G 2x0.55mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID10888628032446
NIH Device Record Keyf455b68a-6733-4571-aa02-953ca7d3a1a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUVÉDERM VOLBELLA XC
Version Model Number95834 
Catalog Number95834 
Company DUNS144796497
Company NameAllergan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8773455372
Emailaus-psreporting@allergan.com
Phone8773455372
Emailaus-psreporting@allergan.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888628032446 [Primary]
GS110888628032460 [Package]
Package: Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-06
Device Publish Date2016-09-06

On-Brand Devices [JUVÉDERM VOLBELLA XC]

10888628043565Juvéderm Volbella XC 32G 2x0.55mL
10888628043541Juvéderm Volbella XC 32G 2x1.0mL
10888628032446Juvéderm Volbella XC 30G 2x0.55mL

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