Catalog Number

610-1082

Brand Name

Ultra-Pro e™ Variable Angle Needle Guide

Version/Model Number

610-1082

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

K092619,K092619

Product Code

IYO

Product Code Name

System, imaging, pulsed echo, ultrasonic

Public Device Record Key

2a3e614a-b494-453c-b66a-1b436eeffaf3

Public Version Date

June 17, 2022

Public Version Number

8

DI Record Publish Date

August 22, 2017

Package DI Number

00841436101943

Quantity per Package

24

Contains DI Package

10841436101940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-