Catalog Number

5415

Brand Name

ProV-Access Vascular Access Needle Guide Kit

Version/Model Number

5415

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

K970889,K973958,K970889,K973958

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

8eb926d9-8438-497e-a02d-5d24e2231afa

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

August 17, 2018

Package DI Number

10841912105714

Quantity per Package

10

Contains DI Package

00841912105717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-