Catalog Number

Roth 018 LR3H

Brand Name

MISO

Version/Model Number

MB181-333

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

768a2ff3-ae75-466c-9e2b-b86b93858430

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 25, 2017

Package DI Number

08800022212779

Quantity per Package

5

Contains DI Package

08800022212762

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-