Catalog Number

-

Brand Name

Anew Implant System

Version/Model Number

ST-18M

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)

Yes

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

68d42719-e5f9-44b5-b720-b545aadfe016

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2015

Package DI Number

07350081494636

Quantity per Package

2

Contains DI Package

07350081495060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Implant pack