Catalog Number

OS200025L

Brand Name

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Version/Model Number

OS200025L

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

e237d1e6-8544-4c1b-b617-e585eac1c720

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

July 24, 2017

Package DI Number

05055662930795

Quantity per Package

10

Contains DI Package

05055662930801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box