Catalog Number

5405SNR

Brand Name

ProV-Access Vascular Access Needle Guide

Version/Model Number

5405

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

K973958,K973958

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

6a73a52d-e6e5-4d61-9ac4-a175f033582b

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

April 27, 2018

Package DI Number

10841912105554

Quantity per Package

10

Contains DI Package

00841912105557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-