Blueprint Mixed Reality MRUE001

GUDID 03700434023824

HOLOBLUEPRINT™

TORNIER

Orthopaedic stereotactic surgery system
Primary Device ID03700434023824
NIH Device Record Keyff287a3a-c240-47c2-bf7c-495a3c731503
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlueprint Mixed Reality
Version Model NumberMRUE001
Catalog NumberMRUE001
Company DUNS260324876
Company NameTORNIER
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700434023824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-13
Device Publish Date2024-08-05

On-Brand Devices [Blueprint Mixed Reality]

03700434023145Headset
03700434022988BP MxR Depth Stop Pin
03700434022957BP MxR Instrument Check Block
03700434022940BP MxR Coracoid Clamp
03700434022933BP MxR Glenoid Digitizer
03700434022926BP MxR Glenoid Pin Guide
03700434016505HOLOBLUEPRINT™
03700434023824HOLOBLUEPRINT™

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