Catalog Number

-

Brand Name

Nitinex Memory Staple

Version/Model Number

ST-121916

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

K112837

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

d5177a92-8a00-4dbc-8059-d8f7bb0a1330

Public Version Date

May 27, 2020

Public Version Number

6

DI Record Publish Date

August 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-