Leksell Vantage Stereotactic System 1040035

GUDID 07340201501337

Neurological stereotactic surgery system

Primary Device ID	07340201501337
NIH Device Record Key	0cf72c39-df82-4f3e-89dc-44426209ec82
Commercial Distribution Status	In Commercial Distribution
Brand Name	Leksell Vantage Stereotactic System
Version Model Number	1040023
Catalog Number	1040035
Company DUNS	353272181
Company Name	Elekta Solutions AB
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07340201501337 [Package] Contains: 07340201501344 Package: [20 Units] In Commercial Distribution
GS1	07340201501344 [Primary]

HAW	Neurological stereotaxic Instrument

Steralize Prior To Use	false
Device Is Sterile	true

07340201502198	Leksell Vantage™ Head Frame
07340201501825	Leksell Vantage™ Head Frame
07340201501764	LEKSELL VANTAGE FRAME HOLDER
07340201501832	MRI FIDUCIAL BOX
07340201501535	Leksell Vantage™ Arc Tray
07340201501382	LEKSELL VANTAGE CT FIDUCIAL BOX
07340048306065	FirmFix™ Ruler
07340201501757	LEKSELL VANTAGE CT INTERFACE
07340201501719	Vantage™ Frame Holder extension
07340201501658	VANTAGE STARBURST 3/8
07340201501634	VANTAGE RADIOLUCENT STARBURST 1/2"
07340201501276	FirmFix™ 2
07340201501252	FirmFix™ 1
07340201501313	FirmFix™ 4
07340201501290	FirmFix™ 3
07340201501337	FirmFix™ 5
07340201501887	LEKSELL VANTAGE ARC SYSTEM
07340201501511	LEKSELL VANTAGE ARC SYSTEM
07340201502129	LEKSELL VANTAGE CARRIER
07340201501504	Leksell Vantage™ Support Arc
07340201501528	Leksell Vantage Key