Catalog Number

MCD715

Brand Name

MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR

Version/Model Number

MCD715

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"

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

-

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

bc1c93dd-8bfd-40c6-a292-ed1ef9942586

Public Version Date

November 06, 2018

Public Version Number

1

DI Record Publish Date

October 06, 2018

Package DI Number

50884908127374

Quantity per Package

10

Contains DI Package

00884908127379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box