Catalog Number

-

Brand Name

Fully Automated Urine Particle Digital Imaging Device UD-10

Version/Model Number

CJ445012

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

K182062

Product Code

JOY

Product Code Name

DEVICE, AUTOMATED CELL-LOCATING

Public Device Record Key

0adcde7f-fb56-4223-b136-542b9f1ba1e2

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-