Catalog Number

94146-2

Brand Name

JUVEDERM ULTRA XC

Version/Model Number

94146-2

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

-

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

34b7920b-9096-4c2e-a4ad-b8d319ddd059

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2014

Package DI Number

30888628000067

Quantity per Package

2

Contains DI Package

10888628000063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box