AVENIO Edge System 09283234001

GUDID 07613336180112

Roche Molecular Systems, Inc.

Laboratory container/microscope slide robotic transfer system IVD
Primary Device ID07613336180112
NIH Device Record Key78b01cf5-ada7-43a4-b870-d12cdae42c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVENIO Edge System
Version Model Number09283234001
Catalog Number09283234001
Company DUNS117676383
Company NameRoche Molecular 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336180112 [Primary]

FDA Product Code

JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

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