Catalog Number

01-5824

Brand Name

OMNIMAX

Version/Model Number

01-5824

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K202969,K831005

Product Code

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Public Device Record Key

610c5089-4b95-46bb-b945-8d5110fdda55

Public Version Date

October 12, 2021

Public Version Number

2

DI Record Publish Date

October 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-