Catalog Number

D1004

Brand Name

Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle

Version/Model Number

D1004

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

-

Product Code

GBZ

Product Code Name

Catheter, Cholangiography

Public Device Record Key

6585e445-ec22-48ad-82f8-1a59815045da

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 24, 2017

Package DI Number

10842102106351

Quantity per Package

10

Contains DI Package

00842102106354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case