Catalog Number

1H16108

Brand Name

ORLUS MINI SCREW

Version/Model Number

1H16108

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

e0705e22-1518-4c3a-a6fb-21baf64c13f7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2015

Package DI Number

08809283890115

Quantity per Package

2

Contains DI Package

08809283890108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case