Leksell GammaPlan 1529980

GUDID 07340048311229

LGP 11.1 SW MEDIA

Elekta Instrument AB

Stereotactic system application software
Primary Device ID07340048311229
NIH Device Record Keyb1f44554-4828-4e8e-b94f-66307f232417
Commercial Distribution Discontinuation2018-11-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLeksell GammaPlan
Version Model Number1529604
Catalog 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
GS107340048311229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem, planning, radiation therapy treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-01
Device Publish Date2018-04-18

On-Brand Devices [Leksell GammaPlan]

07340048311236LGP 11.1
07340048311229LGP 11.1 SW MEDIA

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