Catalog Number

1H16106

Brand Name

ORLUS MINI SCREW

Version/Model Number

1H16106

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

0ba17f1f-dc40-425e-b651-8a5701b4db09

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2015

Package DI Number

08809283890078

Quantity per Package

2

Contains DI Package

08809283890061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case