Leksell Gamma Knife Icon

GUDID 07340048304566

ICON PATIENT CUSION KLARITY

Elekta Instrument AB

Teletherapy radionuclide system, conventional
Primary Device ID07340048304566
NIH Device Record Key4dfa2260-a464-4ee8-a7cc-c97821ee7f64
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Gamma Knife Icon
Version Model Number1528948
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107340048304566 [Package]
Contains: 07340048304573
Package: [20 Units]
In Commercial Distribution
GS107340048304573 [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 Number3
Public Version Date2019-11-01
Device Publish Date2016-09-23

On-Brand Devices [Leksell Gamma Knife Icon]

07340048304917PATIENT MARKERS (10 PCS)
07340048306584QA+ TOOL
07340048306577MR HEAD SUPPORT PERFEXION
07340048306560MR PHILIPS INTERFACE
07340048305624PHANTOM BASE PLATE
07340048305587LEKSELL GAMMA KNIFE ICON
07340048304962MR HEAD SUPPORT PERFEXION
07340048304955MASK ADAPTER ASM
07340048304924PATIENT MARKERS (10 PCS)
07340048304634LGK MASKS EFFICAST (1 PCS)
07340048304610LGK MASK NANOR (1 PCS)
07340048304566ICON PATIENT CUSION KLARITY
07340048311779LEKSELL VANTAGE ADAPTER LGK

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