JUVEDERM ULTRA 93897

GUDID 30888628000036

Juvederm Ultra 30G 2x0.4mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived Dermal tissue reconstructive material, microbe-derived
Primary Device ID30888628000036
NIH Device Record Keyf96506fa-2e0d-417e-a18d-743935e0a846
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUVEDERM ULTRA
Version Model Number93897
Catalog Number93897
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

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888628000032 [Primary]
GS130888628000036 [Package]
Contains: 10888628000032
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 Number4
Public Version Date2018-07-06
Device Publish Date2014-09-17

On-Brand Devices [JUVEDERM ULTRA]

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

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