Catalog Number

21030

Brand Name

MC3 Opus(tm) Vascular Access Kit

Version/Model Number

21030

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

K182914,K182914

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

3fe0e9d5-3dcb-41c4-968b-07112541d85e

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

Package DI Number

20854916006847

Quantity per Package

5

Contains DI Package

10854916006833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box