Catalog Number

-

Brand Name

Euflexxa

Version/Model Number

4100

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"

Yes

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

P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029,P010029

Product Code

MOZ

Product Code Name

Acid, hyaluronic, intraarticular

Public Device Record Key

58bc7279-f90e-40c8-88bc-1d8e67767d6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-