Catalog Number

-

Brand Name

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Version/Model Number

OLYMPUS TGF-UC180J

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

K093507

Product Code

FBN

Product Code Name

Choledochoscope and accessories, flexible/rigid

Public Device Record Key

5737e0eb-4282-45f0-862e-b381046694c1

Public Version Date

October 08, 2018

Public Version Number

5

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-