Leksell Vantage Stereotactic System 1040035

GUDID 07340201501337

FirmFix™ 5

Elekta Solutions AB

Neurological stereotactic surgery system
Primary Device ID07340201501337
NIH Device Record Key0cf72c39-df82-4f3e-89dc-44426209ec82
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Vantage Stereotactic System
Version Model Number1040023
Catalog Number1040035
Company DUNS353272181
Company NameElekta Solutions AB
Device Count1
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 Datefalse
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS107340201501337 [Package]
Contains: 07340201501344
Package: [20 Units]
In Commercial Distribution
GS107340201501344 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

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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