Catalog Number

-

Brand Name

Leica Biosystems DELL 7910 CV Ultimate Service PC

Version/Model Number

23CPU7910ULT_SPARE

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

K042542

Product Code

JOY

Product Code Name

DEVICE, AUTOMATED CELL-LOCATING

Public Device Record Key

95d15449-ec98-478b-9ead-bc78f841b1d1

Public Version Date

August 20, 2020

Public Version Number

4

DI Record Publish Date

March 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-