Catalog Number

71012010

Brand Name

OTHER EXTERNAL FIXATION

Version/Model Number

71012010

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

K994143,K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

1f3f6e50-f2b4-47f5-99d8-67a8569a8066

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

August 29, 2015

Package DI Number

23596010170631

Quantity per Package

5

Contains DI Package

03596010170637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX