WIN10 CPU UPGRADE FOR GSL(IN WARRANTY) - WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY) - Leica Biosystems Richmond, Inc.

Duns Number:082930884

Device Description: WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)

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More Product Details

Catalog Number

-

Brand Name

WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)

Version/Model Number

23GSLWARW10CPU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042542

Product Code Details

Product Code

JOY

Product Code Name

DEVICE, AUTOMATED CELL-LOCATING

Device Record Status

Public Device Record Key

9c615488-18e5-449c-bef4-a76c18357870

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

November 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEICA BIOSYSTEMS RICHMOND, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 206