Extraction tube - HistoCore PEARL Accessory - Leica Biosystems Nussloch GmbH

Duns Number:315539452

Device Description: HistoCore PEARL Accessory

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More Product Details

Catalog Number

14049544881

Brand Name

Extraction tube

Version/Model Number

000000014049544881

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

6b526755-90d5-4b21-9a5d-bea018e9be6b

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 04, 2018

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