Catalog Number

-

Brand Name

SYNVISC

Version/Model Number

HYLAN GF-20

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

-

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Public Device Record Key

6f1100c4-7038-41a1-9a0a-b0519554b1c2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 26, 2015

Package DI Number

65060432190004

Quantity per Package

3

Contains DI Package

25060432190006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-