Catalog Number

-

Brand Name

External Fixator Screw handle

Version/Model Number

5015-1000

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

-

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

K052605

Product Code

KTT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Public Device Record Key

39c7ca9f-4d49-4941-a97f-37189086f5d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-