Leksell Stereotactic System Neurosurgical Instrume

GUDID 07340048307833

STYLET 0.9 MM

Elekta Instrument AB

Neurological stereotactic surgery system
Primary Device ID07340048307833
NIH Device Record Key14343c49-d9a8-4717-9886-7c998b6ccb29
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Stereotactic System Neurosurgical Instrume
Version Model Number1020176
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)693-5358
Emailinfo.america@elekta.com

Device Dimensions

Outer Diameter0.9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107340048307833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07340048307833]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

On-Brand Devices [Leksell Stereotactic System Neurosurgical Instrume]

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

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