Catalog Number

93897

Brand Name

JUVEDERM ULTRA

Version/Model Number

93897

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

P050047,P050047

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

f96506fa-2e0d-417e-a18d-743935e0a846

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 17, 2014

Package DI Number

30888628000036

Quantity per Package

2

Contains DI Package

10888628000032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box