Catalog Number

-

Brand Name

N/A

Version/Model Number

KUM-OE-A62

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

K163614,K163614

Product Code

FDT

Product Code Name

Duodenoscope And Accessories, Flexible/Rigid

Public Device Record Key

f6c6ea25-2687-432e-b276-cc9d7f890451

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

March 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-