Catalog Number

-

Brand Name

N/A

Version/Model Number

DMR190060

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

756e457c-1067-4f28-989f-91ae1c363336

Public Version Date

February 12, 2020

Public Version Number

1

DI Record Publish Date

February 04, 2020

Package DI Number

50884908145101

Quantity per Package

4

Contains DI Package

30884908145107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box