Leksell Stereotactic System

GUDID 07340048306539

FILM HOLDER TOOL

Elekta Instrument AB

Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional

• Primary Device ID: 07340048306539
• NIH Device Record Key: 1d51a603-7e5e-401a-a93c-b2b54880eab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 1002964
• Company DUNS: 507772663
• Company Name: Elekta Instrument AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07340048306539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151159

FDA Product Code

• IWB: System, radiation therapy, radionuclide

Sterilization

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

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