Leksell Vantage Stereotactic System 1040027

GUDID 07340048306065

FirmFix™ Ruler

Elekta Solutions AB

Neurological stereotactic surgery system
Primary Device ID07340048306065
NIH Device Record Key5a810aa0-188d-4a10-8598-2d8d401033fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Vantage Stereotactic System
Version Model Number1040026
Catalog Number1040027
Company DUNS353272181
Company NameElekta Solutions AB
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
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
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
GS107340048306065 [Unit of Use]
GS107340201501368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-26
Device Publish Date2024-06-18

On-Brand Devices [Leksell Vantage Stereotactic System]

07340201502198Leksell Vantage™ Head Frame
07340201501825Leksell Vantage™ Head Frame
07340201501764LEKSELL VANTAGE FRAME HOLDER
07340201501832MRI FIDUCIAL BOX
07340201501535Leksell Vantage™ Arc Tray
07340201501382LEKSELL VANTAGE CT FIDUCIAL BOX
07340048306065FirmFix™ Ruler
07340201501757LEKSELL VANTAGE CT INTERFACE
07340201501719Vantage™ Frame Holder extension
07340201501658VANTAGE STARBURST 3/8
07340201501634VANTAGE RADIOLUCENT STARBURST 1/2"
07340201501276FirmFix™ 2
07340201501252FirmFix™ 1
07340201501313FirmFix™ 4
07340201501290FirmFix™ 3
07340201501337FirmFix™ 5
07340201501887LEKSELL VANTAGE ARC SYSTEM
07340201501511LEKSELL VANTAGE ARC SYSTEM

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