Catalog Number

-

Brand Name

N/A

Version/Model Number

KUMOF-B173K

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

K961564,K961564

Product Code

FDS

Product Code Name

Gastroscope And Accessories, Flexible/Rigid

Public Device Record Key

ab37045a-4411-421d-a59b-1dc0256eba8e

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-