Catalog Number

5000-00020

Brand Name

EPIX Angle Setting Fixture and Lag Screw Pointer

Version/Model Number

5000-00020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FZY

Product Code Name

HAMMER, SURGICAL

Public Device Record Key

3d0ac8db-c37f-45c6-b48b-1ce8969ac4db

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

March 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-