Catalog Number

OS200025LC

Brand Name

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Version/Model Number

OS200025LC

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

K141784,K141784

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

706b0989-8ad0-4331-a4d5-67f0ddfcd258

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

July 24, 2017

Package DI Number

05055662930818

Quantity per Package

10

Contains DI Package

05055662930825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box