Catalog Number

94640

Brand Name

JUVEDERM VOLUMA XC

Version/Model Number

94640

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

a72edca9-8830-419d-8354-d93dde6bb284

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 17, 2014

Package DI Number

30888628000012

Quantity per Package

2

Contains DI Package

10888628000018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box