AVENIO Millisect System PC 08106495001

GUDID 07613336160176

Roche Molecular Systems, Inc.

Slide-mounted-tissue dissection system IVD
Primary Device ID07613336160176
NIH Device Record Key1b7cf033-2f6a-458a-9003-842c2f1a18ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVENIO Millisect System PC
Version Model Number08106495001
Catalog Number08106495001
Company DUNS071674100
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336160176 [Primary]

FDA Product Code

LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

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