JUVEDERM ULTRA XC 93899

GUDID 30888628000074

Juvederm Ultra XC 30G 2x0.4mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID30888628000074
NIH Device Record Key26fe666a-61a3-41b7-a042-73d8e2e42bb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUVEDERM ULTRA XC
Version Model Number93899
Catalog Number93899
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 Perscriptionfalse
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
GS110888628000070 [Primary]
GS130888628000074 [Package]
Contains: 10888628000070
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 XC]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.