Catalog Number

95834 

Brand Name

JUVÉDERM VOLBELLA XC

Version/Model Number

95834 

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

f455b68a-6733-4571-aa02-953ca7d3a1a0

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

10888628032460

Quantity per Package

2

Contains DI Package

10888628032446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box