Catalog Number

5455

Brand Name

Sterile Disposable Endocavity Needle Guide

Version/Model Number

5455

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

K971115,K971722,K971115,K971722

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

43daa0f5-2304-48d7-9b0f-98b3bb463391

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 01, 2022

Package DI Number

10841912107107

Quantity per Package

24

Contains DI Package

00841912107100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-