Catalog Number

-

Brand Name

ORTHOMED

Version/Model Number

OM 47-0472

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

-

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

HTX

Product Code Name

Rongeur

Public Device Record Key

9a3b9bd0-cc93-4ca9-ba2b-dc1567a1c411

Public Version Date

September 06, 2022

Public Version Number

1

DI Record Publish Date

August 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-