Leksell Vantage Stereotactic System 1519663

GUDID 07340048304238

FirmFix™ 2

Elekta Instrument AB

Neurological stereotactic surgery system

• Primary Device ID: 07340048304238
• NIH Device Record Key: aa8d66e1-3e2b-4ed6-9b32-99218fb5369c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Vantage Stereotactic System
• Version Model Number: 1519674
• Catalog Number: 1519663
• Company DUNS: 507772663
• Company Name: Elekta Instrument 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

Customer Support Contacts

• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340048304238 [Package]; Contains: 07340048304245; Package: [20 Units]; In Commercial Distribution
GS1	07340048304245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171123

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-16

On-Brand Devices [Leksell Vantage Stereotactic System]

• 07340048311335: Leksell Vantage Key
• 07340048311281: Leksell Vantage™ Arc Tray
• 07340048311151: Leksell Vantage™ Support Arc
• 07340048305167: Leksell Vantage™ Head Frame
• 07340048304887: ARC CARRIER
• 07340048304870: GUIDE SLIDE
• 07340048304863: STOP SLIDE
• 07340048304856: ARC COMPLETE
• 07340048304849: SUPPORT ARC COMPLETE
• 07340048304832: ARC SUPPORT LEFT
• 07340048304825: ARC SUPPORT RIGHT
• 07340048304818: ARC SLIDE LEFT
• 07340048304801: ARC SLIDE RIGHT
• 07340048304795: ARC Y SCALE RIGHT
• 07340048304788: ARC Y SCALE LEFT
• 07340048304757: MRI PLATE ASSEMBLY RIGHT
• 07340048304726: MRI PLATE ASSEMBLY LEFT
• 07340048304719: MRI FIDUCIAL ARCH POSTERIOR
• 07340048304702: MRI FIDUCIAL ARCH ANTERIOR
• 07340048304696: CROSS HAIR TARGET RING
• 07340048304689: CROSS HAIR TARGET CROSS
• 07340048304672: STARBURST RADIOLUSCENT ADAPTER
• 07340048304665: STARBURST ADAPTER
• 07340048304658: RADIOLUSCENT ADAPTER
• 07340048304412: Leksell Vantage Head Frame Positioning Band
• 07340048304405: LEKSELL VANTAGE CROSS-HAIRS
• 07340048304399: LEKSELL VANTAGE ARC SYSTEM
• 07340048304382: LEKSELL VANTAGE OR ADAPTER
• 07340048304375: MRI FIDUCIAL BOX
• 07340048304368: MRI COIL ADAPTER UPPER STOP
• 07340048304351: MRI COIL ADAPTER UNIVERSAL
• 07340048304344: MRI COIL ADAPTER LOWER STOP
• 07340048304337: MRI COIL ADAPTER LARGE
• 07340048311342: FirmFix™ Ruler
• 07340048304290: FirmFix™ 5
• 07340048304276: FirmFix™ 4
• 07340048304252: FirmFix™ 3
• 07340048304238: FirmFix™ 2
• 07340048304214: FirmFix™ 1
• 07340048304207: Leksell Vantage™ Head Frame
• 07340048311625: VANTAGE STARBURST 3/8
• 07340048311601: VANTAGE RADIOLUCENT STARBURST 1/2"
• 07340048311472: LEKSELL VANTAGE CT INTERFACE
• 07340048311458: Vantage™ Frame Holder extension
• 07340048311434: LEKSELL VANTAGE CT FIDUCIAL BOX
• 07340048311373: LEKSELL VANTAGE FRAME HOLDER
• 07340048311991: MRI COIL ADAPTER LARGE
• 07340048311977: MRI COIL ADAPTER UPPER STOP
• 07340048311953: MRI COIL ADAPTER LOWER STOP
• 07340048312011: MRI COIL ADAPTER UNIVERSAL