Catalog Number

4017

Brand Name

Director Sterile Disposable Needle Gudie

Version/Model Number

4017

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"

Yes

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

K973958,K973958

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

45d2f1db-1a9f-4520-aeb3-ef729cc9526e

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

10841912100993

Quantity per Package

24

Contains DI Package

00841912100996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-