Leksell Stereotactic System

GUDID 07340048301848

FIXATION SCREW L=65 DISPOSABLE

Elekta Instrument AB

Neurological stereotactic surgery system

• Primary Device ID: 07340048301848
• NIH Device Record Key: aab80cef-6d8b-41c5-96a7-8857729a5033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 14010550
• 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: false
• 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

Device Dimensions

• Length: 65 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340048301848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152558

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[07340048301848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Leksell Stereotactic System]

• 07340048311632: FRAME FIXATION STERILIZING TRAY
• 07340048311564: STERILIZING TRAY FOR MULTIPURPOSE ARC
• 07340048311557: STERILIZING TRAY / SMALL
• 07340048311540: STERILIZING CASE FIXATION SCREWS
• 07340048311533: STERILIZING TRAY FOR NEEDLE TESTER
• 07340048311526: STERILIZING TRAY FOR G FRAME KIT
• 07340048311397: INSTRUMENT SCREWDRIVER, DOUBLE
• 07340048305891: MR-INDICATOR, COVER
• 07340048305907: MR-INDICATOR, POSTERIOR
• 07340048305914: MR-Indicator, Anterior
• 07340048305884: MR-INDICATOR, LEFT SIDE
• 07340048305877: MR-INDICATOR, RIGHT SIDE
• 07340048311113: SKULL SCALING INSTRUMENT
• 07340048308120: INSULATED CURVED POST
• 07340048308090: INSULATED FIXATION POST, MEDIUM POSTERIOR
• 07340048308069: POST CURVED
• 07340048306539: FILM HOLDER TOOL
• 07340048306430: YOKE
• 07340048306423: HEADREST SUPPORT
• 07340048306409: EAR PLUG
• 07340048306393: EAR PLUG HOLDER
• 07340048306386: FRAME G-APS W STRAIGHT AND CURVED FRONT
• 07340048306348: FRAME G WITH STRAIGHT AND CURVED FRONT
• 07340048306331: MR-ADAPTER SIEMENS TxRx HEADCOIL
• 07340048306324: MR-ADAPTER SIEMENS TxRx CP
• 07340048306317: MR-ADAPTER TOSHIBA QD HEADCOIL
• 07340048306072: COUNTER SCALE KIT
• 07340048306041: PROBE POINTED
• 07340048306034: TOP PLATE
• 07340048306027: BOTTOM PLATE
• 07340048306003: ANGLE BRACKET
• 07340048305976: X-RAY INDICATOR, POSTERIOR
• 07340048305969: X-RAY INDICATOR, COVER
• 07340048305952: X-RAY INDICATOR, ANTERIOR
• 07340048305860: PLATE HOLDER OPEN MR
• 07340048305853: CT TABLE FIXATION SHORT SIEMENS SOMATOM
• 07340048305846: CT-ADAPTER WITHOUT ATTACHMENT ARMS
• 07340048305839: CT-ADAPTER WITH ATTACHMENT ARMS
• 07340048305822: CT-ADAPTER
• 07340048305815: CROSS HAIR CROSS
• 07340048305808: CROSS HAIR CROSS
• 07340048305792: CROSS HAIR RING
• 07340048305785: CROSS HAIR CROSS
• 07340048305778: CARRIER BASE
• 07340048305761: CARRIER
• 07340048305754: RING HOLDER
• 07340048305747: ARM SECTION
• 07340048305730: HEADREST SUPPORT
• 07340048305723: FRAME SUPPORT, COMPLETE
• 07340048305716: FRAME SUPPORT