Catalog Number

6533-025

Brand Name

DC-OM-CCA, W, INT 145-018

Version/Model Number

LR1BG-057

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

-

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

a87d5980-fe21-4bc9-b702-7aaeb4a7311c

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

10816349011709

Quantity per Package

5

Contains DI Package

00816349011702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-