Catalog Number

-

Brand Name

SINGLE USE CANNULA

Version/Model Number

PR-414Q

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2022

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

K950729,K950729

Product Code

ODD

Product Code Name

Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Public Device Record Key

e0308b19-b08a-47d3-ab9a-d3e98d42927c

Public Version Date

August 15, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170154697

Quantity per Package

6

Contains DI Package

04953170154690

Package Discontinue Date

August 12, 2022

Package Status

Not in Commercial Distribution

Package Type

-