Catalog Number

-

Brand Name

LEVEL ONE CMF

Version/Model Number

995-4743-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2021

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

-

Product Code

MQN

Product Code Name

EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Public Device Record Key

09a779b0-8526-47b7-8581-cfbeddcd637f

Public Version Date

April 21, 2021

Public Version Number

7

DI Record Publish Date

March 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-