BenchMark ULTRA PLUS Instrument 09576797001

GUDID 07613336184608

Ventana Medical Systems, Inc.

Microscope slide stainer IVD
Primary Device ID07613336184608
NIH Device Record Keyb92a1f59-9db4-4f03-b60f-d0efb110e4c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchMark ULTRA PLUS Instrument
Version Model Number09576797001
Catalog Number09576797001
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336184608 [Primary]

FDA Product Code

KPASlide stainer, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

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