Catalog Number

-

Brand Name

ULTRASONIC PROBE

Version/Model Number

UM-DP20-25R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 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"

-

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

K011886

Product Code

FET

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

0faf1a6d-2f4e-4b8c-b17c-f42832f56e3f

Public Version Date

August 11, 2022

Public Version Number

8

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-