Catalog Number

-

Brand Name

LEVEL ONE CMF

Version/Model Number

25-099-16-09

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

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Public Device Record Key

4c7b8ec8-4774-4577-8067-148131221b72

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

-