Catalog Number

-

Brand Name

GEO Staple System

Version/Model Number

14118183

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

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

-

Product Code

JDR

Product Code Name

Staple, fixation, bone

Public Device Record Key

ccf1806d-b310-4cd1-a53b-c0f5e5b22ac8

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-