Catalog Number

-

Brand Name

Supartz

Version/Model Number

NA

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

P980044,P980044

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Public Device Record Key

2542a882-955f-4fa1-8abb-4cddaa21d0fa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

5060459970137

Quantity per Package

5

Contains DI Package

05060459970120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-