Catalog Number

HTR-04-009209

Brand Name

Orion Headed Screw System Instruments

Version/Model Number

HTR-04-009209

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PXV

Product Code Name

General purpose instrument tray

Public Device Record Key

3f2f33f1-68d1-48a8-9699-e41e8c16bfb4

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

December 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-