Catalog Number

2O16207

Brand Name

ORLUS MINI SCREW

Version/Model Number

2O16207

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

ab5f7928-1c93-44e4-b762-9ead78e90b44

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2015

Package DI Number

08809283891259

Quantity per Package

2

Contains DI Package

08809283891242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case