Catalog Number

-

Brand Name

Stapix Superelastic Nitinol Staple System

Version/Model Number

SK101010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2019

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)

-

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

faf81dfb-a2dc-4ea9-94c3-004bc433b138

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

October 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-