Leksell GammaPlan

GUDID 07340201502136

Leksell GammaPlan

Elekta Solutions AB

Stereotactic system application software
Primary Device ID07340201502136
NIH Device Record Key61d2e8e0-c2b5-4549-a09d-296e80fecf04
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell GammaPlan
Version Model Number1567714
Company DUNS353272181
Company NameElekta Solutions 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com
Phone8556935358
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340201502136 [Primary]

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 Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

Devices Manufactured by Elekta Solutions AB

07340201503478 - Leksell Stereotactic System2025-07-29 TITANIUM FIXATION SCREW, KIT 5 PAIRS
07340201502280 - Leksell Stereotactic System2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP
07340201502860 - Leksell Stereotactic System2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP, Headrest support, ingoing part of 1040304.
07340201502877 - Leksell Stereotactic System2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP, Clamp Spacer, ingoing part of 1040304.
07340201502884 - Leksell Stereotactic System2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP, Frame support, ingoing part of 1040304.
07340201502297 - Leksell Stereotactic System2025-07-11 STERILIZING TRAY FOR G FRAME KIT
07340201503263 - Leksell Stereotactic System2025-07-11 FRAME G
07340201502341 - Leksell Stereotactic System2025-07-09 OPEN MR-INDICATOR

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