Catalog Number

-

Brand Name

Chocolate®

Version/Model Number

CB1812050080OTW

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

K130414

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

4c7ff194-1cc8-4975-8aa0-47aac14334c0

Public Version Date

March 17, 2022

Public Version Number

2

DI Record Publish Date

October 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-