Catalog Number

OS326928-NS

Brand Name

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Version/Model Number

OS326928-NS

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

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

660d7eb7-cedf-4de1-8327-02af90cb0d9d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-