Catalog Number

110030060

Brand Name

Comprehensive® Shoulder System

Version/Model Number

110030060

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152754,K202232

Product Code

PHX

Product Code Name

shoulder prosthesis, reverse configuration

Public Device Record Key

5dee9127-1599-4f33-9bf8-c083d71f3036

Public Version Date

September 16, 2022

Public Version Number

11

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-