Catalog Number

-

Brand Name

AGILON® XO trial glenosphere

Version/Model Number

78034046

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

-

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

PHX

Product Code Name

Shoulder Prosthesis, Reverse Configuration

Public Device Record Key

e2c0abb5-59fc-4dff-b9c3-5cbf891a74e2

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-