Catalog Number

-

Brand Name

Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM

Version/Model Number

232FLAL311972

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

b40bc2da-ce68-409f-b65b-b9aa9466eca0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-