Unibody™

GUDID 20613994747840

FIDUCIALS FM-4013 IMAGE 13mm GLOBAL AIMD

MEDTRONIC, INC.

Neurological stereotactic surgery system
Primary Device ID20613994747840
NIH Device Record Key835e5ed4-dd4a-4024-b664-fc74fffdbe6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnibody™
Version Model NumberFM-4013
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994747846 [Unit of Use]
GS120613994747840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-17

On-Brand Devices [Unibody™]

20613994747840FIDUCIALS FM-4013 IMAGE 13mm GLOBAL AIMD
20613994747833FIDUCIAL FM-4010 IMAGE 10MM GLOBAL AIMD
20613994747826FIDUCIALS FM-4007 IMAGE 7mm GLOBAL AIMD

Trademark Results [Unibody]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIBODY
UNIBODY
98004269 not registered Live/Pending
Bauer Beauty Company, LLC
2023-05-19
UNIBODY
UNIBODY
90413782 not registered Live/Pending
TOZO INC
2020-12-25
UNIBODY
UNIBODY
87537996 5412147 Live/Registered
EPIC LIFT SYSTEMS LLC
2017-07-21
UNIBODY
UNIBODY
87106523 5262468 Live/Registered
Creative Clouds, Inc.
2016-07-17
UNIBODY
UNIBODY
86627663 not registered Dead/Abandoned
OFS Fitel, LLC
2015-05-13
UNIBODY
UNIBODY
79034253 3312952 Live/Registered
Genmab A/S
2006-10-19
UNIBODY
UNIBODY
78868052 3187448 Live/Registered
JANSAN ACQUISITION, LLC
2006-04-24
UNIBODY
UNIBODY
78753188 3745452 Live/Registered
Medtronic, Inc.
2005-11-14
UNIBODY
UNIBODY
78362092 not registered Dead/Abandoned
Mendoza, Mary Kate
2004-02-04
UNIBODY
UNIBODY
78227606 2902380 Dead/Cancelled
OFS FITEL, LLC
2003-03-19
UNIBODY
UNIBODY
77540455 3875098 Dead/Cancelled
BAYCOR FIBRE TECH INC.
2008-08-06
UNIBODY
UNIBODY
75635177 2448229 Dead/Cancelled
TRAVELPRO INTERNATIONAL, INC.
1999-02-05

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