Catalog Number

OS200125

Brand Name

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Version/Model Number

OS200125

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

HTW

Product Code Name

Bit, Drill

Public Device Record Key

221b7506-8b6f-4952-ad0f-b2c5121a6e03

Public Version Date

April 16, 2019

Public Version Number

5

DI Record Publish Date

July 29, 2016

Package DI Number

05055662931099

Quantity per Package

10

Contains DI Package

05055662931105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box