Leksell Vantage Stereotactic System

GUDID 07340201502129

LEKSELL VANTAGE CARRIER

Elekta Solutions AB

Neurological stereotactic surgery system
Primary Device ID07340201502129
NIH Device Record Key6c84bb10-d2e5-4382-97c7-4cae93b6c3b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Vantage Stereotactic System
Version Model Number1040136
Company DUNS353272181
Company NameElekta Solutions AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
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
GS107340201502129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


[07340201502129]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-29

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
07340201502129LEKSELL VANTAGE CARRIER
07340201501504Leksell Vantage™ Support Arc
07340201501528Leksell Vantage Key

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