Catalog Number

71679280

Brand Name

CHS

Version/Model Number

71679280

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 16, 2018

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

K080434

Product Code

JDO

Product Code Name

DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Public Device Record Key

14dc17a8-2148-44ac-9cde-f7140d7fa9f7

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-