Leksell GammaPlan

GUDID 07340048311236

LGP 11.1

Elekta Instrument AB

Stereotactic system application software
Primary Device ID07340048311236
NIH Device Record Key6cb9c85f-2c48-431a-ac3b-583b9dc4e400
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell GammaPlan
Version Model Number1529980
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 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 Identifiers

Device Issuing AgencyDevice ID
GS107340048311236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, radiation therapy, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-10

On-Brand Devices [Leksell GammaPlan]

07340048311236LGP 11.1
07340048311229LGP 11.1 SW MEDIA

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