Catalog Number

-

Brand Name

Encore Stem Trial Neck

Version/Model Number

111-45-0416

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2022

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

-

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

K211505

Product Code

HWT

Product Code Name

Template

Public Device Record Key

b938d88a-5fe2-45e2-ab41-84fb757f07e4

Public Version Date

August 18, 2022

Public Version Number

2

DI Record Publish Date

October 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-