Catalog Number

-

Brand Name

Vaxcel

Version/Model Number

45993

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K974640,K974640

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

12feb1dc-31f9-4b9a-9b6e-f04313191e36

Public Version Date

August 13, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

M001459931

Quantity per Package

10

Contains DI Package

M001459930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX