Leksell Stereotactic System

GUDID 07340201502334

DISPOSABLE INSERTS 4 PCS

Elekta Solutions AB

Neurological stereotactic surgery system
Primary Device ID07340201502334
NIH Device Record Key21124e54-2400-48d7-85a5-6aef052af399
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Stereotactic System
Version Model Number1040153
Company DUNS353272181
Company NameElekta Solutions AB
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340201502334 [Unit of Use]
GS107340201502594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


[07340201502334]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-20
Device Publish Date2025-02-12

Devices Manufactured by Elekta Solutions AB

07340201502204 - Leksell Vantage Stereotactic System2025-04-10 CT TABLE FIXATION UNIVERSAL
07340201502211 - Leksell Vantage Stereotactic System2025-04-10 CT table Fixation Siemens
07340201502228 - Leksell Vantage Stereotactic System2025-04-10 CT TABLE FIXATION PHILIPS
07340201502235 - Leksell Vantage Stereotactic System2025-04-10 CT TABLE FIXATION GE
07340201502242 - Leksell Vantage Stereotactic System2025-04-10 CT TABLE FIXATION TOSHIBA
07340201501863 - Leksell Vantage Stereotactic System2025-04-09 ARC SUPPORT LEFT
07340201501870 - Leksell Vantage Stereotactic System2025-04-09 ARC SUPPORT RIGHT
07340201501931 - Leksell Vantage Stereotactic System2025-04-09 ARC SLIDE LEFT

Trademark Results [Leksell Stereotactic System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEKSELL STEREOTACTIC SYSTEM
LEKSELL STEREOTACTIC SYSTEM
75257621 not registered Dead/Abandoned
Elekta AB
1997-03-13
LEKSELL STEREOTACTIC SYSTEM
LEKSELL STEREOTACTIC SYSTEM
73391725 not registered Dead/Abandoned
AKTIEBOLAGET ELEKTA-INSTRUMENT
1982-09-29

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