Catalog Number

-

Brand Name

OLYMPUS

Version/Model Number

KD-625QR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 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

K182408,K182408

Product Code

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

e3eb3b2b-5788-44aa-94d1-14fa78c7bc21

Public Version Date

February 22, 2022

Public Version Number

2

DI Record Publish Date

May 21, 2019

Package DI Number

14953170407830

Quantity per Package

1

Contains DI Package

04953170407833

Package Discontinue Date

February 21, 2022

Package Status

Not in Commercial Distribution

Package Type

-