ASP6025 S 230V/50-60Hz - The ASP6025 S Tissue Processor is a modular - Leica Biosystems Nussloch GmbH

Duns Number:315539452

Device Description: The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.

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More Product Details

Catalog Number

14049559058

Brand Name

ASP6025 S 230V/50-60Hz

Version/Model Number

000000014049559058

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IEO

Product Code Name

PROCESSOR, TISSUE, AUTOMATED

Device Record Status

Public Device Record Key

509795c1-fa5d-4451-8976-3ba84f3982b8

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

July 05, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEICA BIOSYSTEMS NUSSLOCH GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 97