JUVEDERM ULTRA PLUS XC 96209

GUDID 10888628044777

Juvéderm ULTRA PLUS XC 2x0.55mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID10888628044777
NIH Device Record Keyfea65201-14e3-4173-8b7d-1c90245f6907
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUVEDERM ULTRA PLUS XC
Version Model Number96209
Catalog Number96209
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 Producttrue
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

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888628044777 [Package]
Contains: 10888628044784
Package: Box [2 Units]
In Commercial Distribution
GS110888628044784 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

On-Brand Devices [JUVEDERM ULTRA PLUS XC]

30888628000111Juvederm Ultra PLUS XC 27G 2x1.0mL
30888628000104Juvederm Ultra PLUS XC 27G 2x0.4mL
30888628000098Juvederm Ultra PLUS XC 27G 1x0,8mL
10888628044777Juvéderm ULTRA PLUS XC 2x0.55mL

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