Catalog Number

162644

Brand Name

Distal Centralizer/Centering Sleeve

Version/Model Number

162644

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

K193546,K942479

Product Code

JDG

Product Code Name

Prosthesis, hip, femoral component, cemented, metal

Public Device Record Key

e353b133-5fee-4c39-9265-d550a72e2d75

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-