Catalog Number

CX14-140-3015 RX

Brand Name

CHOCOLATE

Version/Model Number

IPN914596

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

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Public Device Record Key

c4010dde-1699-4eb6-912c-e6f0b45e6ad0

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 2021

Package DI Number

20841156105478

Quantity per Package

1

Contains DI Package

10841156105471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box