Catalog Number

-

Brand Name

Orthofix Proview

Version/Model Number

70-2304

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 2022

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

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

40cf9551-16d2-4484-b717-5686d3467f28

Public Version Date

April 14, 2022

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-