Catalog Number

405800

Brand Name

Comprehensive® Reverse Shoulder

Version/Model Number

405800

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

K132239,K193373

Product Code

FZX

Product Code Name

Guide, surgical, instrument

Public Device Record Key

f6172680-d6f2-4f82-9994-53c737ab53ff

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-