Catalog Number

-

Brand Name

WK-86 LT

Version/Model Number

30027001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2018

Issuing Agency

In HIBCC

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

-

Product Code

FDA

Product Code Name

Enteroscope And Accessories

Public Device Record Key

7d2ff0c0-0bb9-4bf3-adb4-c300019d9903

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-