Catalog Number

72010-01

Brand Name

Diamondback Coronary

Version/Model Number

GWC-12325LG-FLP

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"

-

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

P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005,P130005

Product Code

MCX

Product Code Name

Catheter, Coronary, Atherectomy

Public Device Record Key

f6cbb4b9-e9d9-49c5-a07c-005a6b09f170

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2014

Package DI Number

30852528005187

Quantity per Package

5

Contains DI Package

10852528005183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box