Catalog Number

657-014

Brand Name

Needle Guide

Version/Model Number

657-014

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

K970514,K970514

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

acf4994a-69b7-4697-ba1e-c4c4317027ec

Public Version Date

June 17, 2022

Public Version Number

8

DI Record Publish Date

August 22, 2017

Package DI Number

00841436106061

Quantity per Package

24

Contains DI Package

10841436106068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-