Leksell Stereotactic System

GUDID 07340048305747

ARM SECTION

Elekta Instrument AB

Neurological stereotactic surgery system
Primary Device ID07340048305747
NIH Device Record Keye0fd4f31-59bc-4b6d-b1fc-30c3a6b1fe70
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Stereotactic System
Version Model Number1003534
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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(855)693-5358
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340048305747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07340048305747]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

On-Brand Devices [Leksell Stereotactic System]

07340048311632FRAME FIXATION STERILIZING TRAY
07340048311564STERILIZING TRAY FOR MULTIPURPOSE ARC
07340048311557STERILIZING TRAY / SMALL
07340048311540STERILIZING CASE FIXATION SCREWS
07340048311533STERILIZING TRAY FOR NEEDLE TESTER
07340048311526STERILIZING TRAY FOR G FRAME KIT
07340048311397INSTRUMENT SCREWDRIVER, DOUBLE
07340048305891MR-INDICATOR, COVER
07340048305907MR-INDICATOR, POSTERIOR
07340048305914MR-Indicator, Anterior
07340048305884MR-INDICATOR, LEFT SIDE
07340048305877MR-INDICATOR, RIGHT SIDE
07340048311113SKULL SCALING INSTRUMENT
07340048308120INSULATED CURVED POST
07340048308090INSULATED FIXATION POST, MEDIUM POSTERIOR
07340048308069POST CURVED
07340048306539FILM HOLDER TOOL
07340048306430YOKE
07340048306423HEADREST SUPPORT
07340048306409EAR PLUG
07340048306393EAR PLUG HOLDER
07340048306386FRAME G-APS W STRAIGHT AND CURVED FRONT
07340048306348FRAME G WITH STRAIGHT AND CURVED FRONT
07340048306331MR-ADAPTER SIEMENS TxRx HEADCOIL
07340048306324MR-ADAPTER SIEMENS TxRx CP
07340048306317MR-ADAPTER TOSHIBA QD HEADCOIL
07340048306072COUNTER SCALE KIT
07340048306041PROBE POINTED
07340048306034TOP PLATE
07340048306027BOTTOM PLATE
07340048306003ANGLE BRACKET
07340048305976X-RAY INDICATOR, POSTERIOR
07340048305969X-RAY INDICATOR, COVER
07340048305952X-RAY INDICATOR, ANTERIOR
07340048305860PLATE HOLDER OPEN MR
07340048305853CT TABLE FIXATION SHORT SIEMENS SOMATOM
07340048305846CT-ADAPTER WITHOUT ATTACHMENT ARMS
07340048305839CT-ADAPTER WITH ATTACHMENT ARMS
07340048305822CT-ADAPTER
07340048305815CROSS HAIR CROSS
07340048305808CROSS HAIR CROSS
07340048305792CROSS HAIR RING
07340048305785CROSS HAIR CROSS
07340048305778CARRIER BASE
07340048305761CARRIER
07340048305754RING HOLDER
07340048305747ARM SECTION
07340048305730HEADREST SUPPORT
07340048305723FRAME SUPPORT, COMPLETE
07340048305716FRAME SUPPORT

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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