Catalog Number

006570

Brand Name

Orthofix Pro-View Minimal Access Portal System

Version/Model Number

70-2304

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

4469288d-2b19-4848-9754-0fff339c7d85

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2021

Package DI Number

10812432022409

Quantity per Package

5

Contains DI Package

00812432022402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton