Catalog Number

0431582805

Brand Name

NA

Version/Model Number

04.315.828.05

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162594,K170818,K162594,K170818

Product Code

MQN

Product Code Name

EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Public Device Record Key

9c4154d3-9827-4be2-b326-4a13edfe047d

Public Version Date

April 25, 2022

Public Version Number

2

DI Record Publish Date

December 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-