Catalog Number

ERCP-1-HKB-D

Brand Name

Huibregtse Katon

Version/Model Number

G57289

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

K171989

Product Code

ODD

Product Code Name

Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Public Device Record Key

46861d1c-a71a-4ed6-bef5-957719e84e44

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

April 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-