Leksell Stereotactic System Neurosurgical Instrume

GUDID 07340048308038

DISPOSABLE STOP AND GUIDE

Elekta Instrument AB

Neurological stereotactic surgery system
Primary Device ID07340048308038
NIH Device Record Key1bf01b1f-18c3-42bd-8182-992dbd881355
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Stereotactic System Neurosurgical Instrume
Version Model Number911934
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS107340048308038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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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