Catalog Number

OM 71-0678R

Brand Name

ORTHOMED

Version/Model Number

OM 71-0678R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

e0e34805-94a7-4c5a-8930-c725eb4d5953

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

B8037106783

Quantity per Package

6

Contains DI Package

B803710678R0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

TUBE