Catalog Number

110019066

Brand Name

Comprehensive® VRS Glenoid

Version/Model Number

110019066

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

K152754,K202232

Product Code

PHX

Product Code Name

shoulder prosthesis, reverse configuration

Public Device Record Key

57f6ed23-edf6-4bc9-8d93-fdee31fd0c91

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-