Catalog Number

-

Brand Name

Orthovisc

Version/Model Number

NA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2018

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)

-

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

05e476cd-1f63-48f6-bd85-06503bd39273

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-