Leksell Gamma Knife Perfexion/Icon

GUDID 07340048306546

QA FILM HOLDER

Elekta Instrument AB

Teletherapy radionuclide system, conventional
Primary Device ID07340048306546
NIH Device Record Keya1e59e46-b166-4816-a059-5fc7edff744e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Gamma Knife Perfexion/Icon
Version Model NumberA0202-04
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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 Identifiers

Device Issuing AgencyDevice ID
GS107340048306546 [Primary]

FDA Product Code

IWBSystem, radiation therapy, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Leksell Gamma Knife Perfexion/Icon]

07340048309516FRAME FIXATION ADAPTER
07340048307963FRAME FIXATION ADAPTER
07340048306591CC EXCHANGE TOOL
07340048306553CLEARENCE CHECK TOOL
07340048306546QA FILM HOLDER
07340048306522FRAME CAP
07340048306454DOSIMETRY PHANTOM
07340048306188RADIATION PHANTOM WITH CASSETTES
07340048305617PHANTOM ADAPTER COMPLETE
07340048306447LEKSELL GAMMA KNIFE DOSIMETRY PHANTOM
07340048305112POST INSULATED LONG POSTERIOR
07340048311762Dosimetry Phantom Vantage LGK
07340048311755QA TOOL VANTAGE LGK
07340048311731Dosimetry Phantom Vantage Base
07340048311700FILM HOLDER VANTAGE LGK

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