Leksell Stereotactic System Neurosurgical Instrume

GUDID 07340048307833

STYLET 0.9 MM

Elekta Instrument AB

Neurological stereotactic surgery system

• Primary Device ID: 07340048307833
• NIH Device Record Key: 14343c49-d9a8-4717-9886-7c998b6ccb29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System Neurosurgical Instrume
• Version Model Number: 1020176
• Company DUNS: 507772663
• Company Name: Elekta Instrument AB
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

• Outer Diameter: 0.9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340048307833 [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

[07340048307833]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-21

On-Brand Devices [Leksell Stereotactic System Neurosurgical Instrume]

• 07340048311380: NEEDLE WITH LUER LOCK
• 07340048308656: HAEMATOMA EVACUATOR 4.0 MM
• 07340048308649: LUER CONNECTION NEEDLE
• 07340048308632: INSERTION CANNULA 190/1.6
• 07340048308625: CATHETHER INSERTION NEEDLE / 2.6 MM
• 07340048308618: CATH. INSERTION NEEDLE / 1.5 MM
• 07340048308601: SALCMAN TWIST DRILL 2.1/3.2
• 07340048308595: SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT 2
• 07340048308588: SEDAN CUTTING NEEDLE 2.5 MM
• 07340048308571: TWIST DRILL 3.2 MM
• 07340048308564: TWIST DRILL 2.1 MM
• 07340048308038: DISPOSABLE STOP AND GUIDE
• 07340048308014: DISPOSABLE BIOPSY NEEDLE AND ASPIRATION TUBE
• 07340048308007: DISPOSABLE BIOPSY NEEDLE KIT
• 07340048307833: STYLET 0.9 MM
• 07340048307819: INJECTION/ASPIRATION NEEDLE KIT
• 07340048307802: STYLET 1.6 MM
• 07340048307796: CANNULA 2.1 MM
• 07340048307772: STYLET 1.9
• 07340048307765: CANNULA 2.6
• 07340048307758: INSERTION SLEEVE 3.5
• 07340048307727: STYLET 0.9 MM
• 07340048307710: CANNULA 1.5 MM
• 07340048307703: INSERTION SLEEVE 2.1 MM
• 07340048307680: ADJUSTABLE / STOP 3.2 MM
• 07340048307673: ADJUSTABLE / STOP 2.1 MM
• 07340048307666: REDUCING TUBE
• 07340048307659: DRILL SLEEVE LONG
• 07340048307642: DRILL SLEEVE 4 MM
• 07340048307635: TWIST DRIL 3.2 MM
• 07340048307628: TWIST DRILL 2.1 MM
• 07340048307604: INNER CANNULA D=1,5 BIOPSY L=5
• 07340048307598: OUTER CANNULA D=2.1 BIOPSY L=5 ASM
• 07340048307574: SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT 2
• 07340048307567: INNER CANNULA D=2.0 BIOPSY L=10
• 07340048307550: OUTER CANNULA D=2.5 L=10
• 07340048304948: STOP WITH 1.5 MM HOLE
• 07340048304931: GUIDE WITH 1.5 MM HOLE
• 07340048302708: GUIDE WITH 6.0 MM HOLE
• 07340048302692: GUIDE WITH 4.0 MM HOLE
• 07340048302685: GUIDE WITH 3.5 MM HOLE
• 07340048302678: GUIDE WITH 3.2 MM HOLE
• 07340048302661: GUIDE WITH 2.5 MM HOLE
• 07340048302654: GUIDE WITH 2.1 MM HOLE
• 07340048302630: STOP WITH 6.0 MM HOLE
• 07340048302623: STOP WITH 4.0 MM HOLE
• 07340048302616: STOP WITH 3.5 MM HOLE
• 07340048302609: STOP WITH 3.2 MM HOLE
• 07340048302593: STOP WITH 2.5 MM HOLE
• 07340048302586: STOP WITH 2.1 MM HOLE