Catalog Number

-

Brand Name

Agee TurnKey FCS®

Version/Model Number

FCS-400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 02, 2021

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)

Yes

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

K072432

Product Code

JEC

Product Code Name

Component, Traction, Invasive

Public Device Record Key

e803dfba-7b36-4f78-8a55-890f3e1e402b

Public Version Date

February 03, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-