Catalog Number

8045-44

Brand Name

Legacy™ Plastic Engaging Castable Abutment

Version/Model Number

8045-44

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 22, 2019

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

-

Product Code Name

-

Public Device Record Key

4267ae5a-f3ba-441c-8128-d5172db49788

Public Version Date

September 13, 2019

Public Version Number

4

DI Record Publish Date

December 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-