Catalog Number

1068228

Brand Name

Biomet EBI Bone Healing System

Version/Model Number

1068228

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

P790002

Product Code

LOF

Product Code Name

Stimulator, Bone Growth, Non-Invasive

Public Device Record Key

fd13cd2b-e3af-4822-be66-9a60721ff3da

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-