Catalog Number

1O18210

Brand Name

ORLUS MINI SCREW

Version/Model Number

1O18210

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

fb341efa-6c12-4fa5-bc15-ca7ba7cf443f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 01, 2016

Package DI Number

08809283891778

Quantity per Package

2

Contains DI Package

08809283891761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case