VENTANA HE 600 System - Ventana Medical Systems, Inc.

Duns Number:184042521

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More Product Details

Catalog Number

06917259001

Brand Name

VENTANA HE 600 System

Version/Model Number

06917259001

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

-

Product Code Details

Product Code

KPA

Product Code Name

Slide stainer, automated

Device Record Status

Public Device Record Key

d7fa34a8-29bb-4e30-817f-dfdc7fbde7c7

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VENTANA MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 134
2 A medical device with a moderate to high risk that requires special controls. 11
3 A medical device with high risk that requires premarket approval 7