Catalog Number

DMC45J

Brand Name

N/AN/A

Version/Model Number

DMC45J

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

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

9ed77fc5-5aeb-47a6-a515-86bd5916edcd

Public Version Date

September 13, 2019

Public Version Number

1

DI Record Publish Date

September 05, 2019

Package DI Number

30884908145183

Quantity per Package

10

Contains DI Package

00884908145182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box