Adapter for DRS601/Varistain XY - Leica Biosystems Accessory - Leica Biosystems Nussloch GmbH

Duns Number:315539452

Device Description: Leica Biosystems Accessory

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More Product Details

Catalog Number

14046437058

Brand Name

Adapter for DRS601/Varistain XY

Version/Model Number

000000014046437058

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

KIM

Product Code Name

DEVICE FOR SEALING MICROSECTIONS

Device Record Status

Public Device Record Key

40b4b46e-e67f-4f8a-aaba-f4c223a1b7a2

Public Version Date

August 20, 2020

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