Catalog Number

96181

Brand Name

JUVÉDERM VOLBELLA XC

Version/Model Number

96181

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

f693b4f2-4c23-47f0-b00b-d1f42fc83b3e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 02, 2017

Package DI Number

10888628043541

Quantity per Package

2

Contains DI Package

10888628043558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box