Catalog Number

Roth 018 UR3H

Brand Name

MISO

Version/Model Number

MB181-133

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

-

Product Code

NJM

Product Code Name

Bracket, Ceramic, Orthodontic

Public Device Record Key

bbf784c8-035f-4e9f-859e-f1c75f2f7b39

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 25, 2017

Package DI Number

08800022212632

Quantity per Package

5

Contains DI Package

08800022212625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-