Catalog Number

610-1187, 610-1198

Brand Name

RAD-Guide Needle Guide

Version/Model Number

610-1187, 610-1198

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

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

2b8a97c3-2517-48eb-86f4-3e4268803e54

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

August 22, 2017

Package DI Number

00841436102315

Quantity per Package

5

Contains DI Package

10841436102305

Package Discontinue Date

December 17, 2020

Package Status

Not in Commercial Distribution

Package Type

-