AVENIO Millisect Tip Large 08106525001

GUDID 07613336146606

Roche Molecular Systems, Inc.

Slide-mounted-tissue dissection system excision tip IVD
Primary Device ID07613336146606
NIH Device Record Keya417bef6-074b-4fa7-af50-9400def901d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVENIO Millisect Tip Large
Version Model Number08106525001
Catalog Number08106525001
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 Usetrue
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
GS107613336146606 [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

Devices Manufactured by Roche Molecular Systems, Inc.

04015630936540 - cobas p630 Pre-Analytical Pipettor2022-09-16
04015630936557 - DOCKING STATION SHORT2022-09-16
00875197006445 - cobas® NHP Negative Control Kit2022-08-09
04015630929009 - cobas x 480 Analyzer2022-06-10
00875197006391 - cobas® HCV2021-12-22
00875197006407 - cobas® HIV-12021-12-22
00875197006414 - cobas® HBV2021-12-22
00875197006421 - cobas® CMV2021-12-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.