Catalog Number

LNGO-2022

Brand Name

Open Needle Guide

Version/Model Number

LNGO-2022

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

K983621,K983621,K983621,K983621

Product Code

IZH

Product Code Name

System, x-ray, mammographic

Public Device Record Key

520fc6a5-116d-4ce6-885f-ac6c16f9c1c4

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

10813079020421

Quantity per Package

10

Contains DI Package

00813079020424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton