Catalog Number

96207

Brand Name

JUVEDERM ULTRA XC

Version/Model Number

96207

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

Yes

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

8371cb1c-aec6-4658-8dba-478cd30e461e

Public Version Date

April 30, 2019

Public Version Number

1

DI Record Publish Date

April 22, 2019

Package DI Number

10888628044753

Quantity per Package

2

Contains DI Package

10888628044760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box