Catalog Number

-

Brand Name

PENTAX

Version/Model Number

OF-B77

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

-

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

K963056

Product Code

FDT

Product Code Name

duodenoscope and accessories, flexible/rigid

Public Device Record Key

9c00b530-3093-49cf-97ea-4dca87ab81e2

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

April 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-