Catalog Number

-

Brand Name

Ultrasound Probe Cover Biopsy Needle Guide

Version/Model Number

28-GG225

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K011265,K011265

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

10b5046c-18f0-4064-8810-76361afc383e

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

10848340015233

Quantity per Package

10

Contains DI Package

00848340015236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-