Catalog Number

20073770

Brand Name

JUVEDERM VOLUX XC

Version/Model Number

20073770

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

13fa4817-c6bd-46e4-9f38-c4fb1aaba5f1

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

30840228300077

Quantity per Package

2

Contains DI Package

10840228300073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box