Catalog Number

95661

Brand Name

JUVEDERM VOLLURE XC

Version/Model Number

95661

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P110033,P110033

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

afa47a09-c250-4abf-b8a7-be6b829e98c7

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 21, 2017

Package DI Number

10888628034471

Quantity per Package

2

Contains DI Package

10888628034488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box