Catalog Number

-

Brand Name

Atlas Implant System

Version/Model Number

AT-22M

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

8ce3e9d6-d978-4290-bb96-400bd6acb622

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 23, 2015

Package DI Number

07350081494544

Quantity per Package

2

Contains DI Package

07350081494988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Implant pack