Catalog Number

10-1328M

Brand Name

EBI OsteoGen™ Implantable Bone Growth Stimulator

Version/Model Number

10-1328M

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

P790005

Product Code

LOE

Product Code Name

Stimulator, Invasive Bone Growth

Public Device Record Key

f5537a42-87a6-4e82-86e2-cbffc8c224b6

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

-