Catalog Number

-

Brand Name

SonoScape

Version/Model Number

EC-550L

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

K211882

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

e43b8983-d8e3-4673-94fc-afaa2dc21c6c

Public Version Date

April 15, 2022

Public Version Number

1

DI Record Publish Date

April 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-