Catalog Number

93898

Brand Name

JUVEDERM ULTRA PLUS

Version/Model Number

93898

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)

-

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

6ab51d8c-3979-41e4-ac53-41d78aa6cb6a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 17, 2014

Package DI Number

30888628000050

Quantity per Package

2

Contains DI Package

10888628000056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box