Catalog Number

CCL2-1050HB

Brand Name

Chole-Cath Biliary Drainage Catheter

Version/Model Number

CCL2-1050HB

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

K923096,K923096,K923096

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Public Device Record Key

d5157ace-457c-4de5-b698-c0554a2a8357

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Package DI Number

10817640021152

Quantity per Package

5

Contains DI Package

00817640021155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser