Leksell Gamma Knife Esprit

GUDID 07340201501139

Elekta Esprit

Elekta Solutions AB

Teletherapy radionuclide system, conventional
Primary Device ID07340201501139
NIH Device Record Keyf07ed625-081f-4ca0-a62c-84df9ce58627
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Gamma Knife Esprit
Version Model Number1110200
Company DUNS353272181
Company NameElekta Solutions AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107340201501139 [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 Date2023-04-04
Device Publish Date2023-03-27

Devices Manufactured by Elekta Solutions AB

07340201501528 - Leksell Vantage Stereotactic System2024-12-09 Leksell Vantage Key
07340201501504 - Leksell Vantage Stereotactic System2024-12-09 Leksell Vantage™ Support Arc
07340201502129 - Leksell Vantage Stereotactic System2024-12-09 LEKSELL VANTAGE CARRIER
07340201501511 - Leksell Vantage Stereotactic System2024-09-09 LEKSELL VANTAGE ARC SYSTEM
07340201501887 - Leksell Vantage Stereotactic System2024-08-22 LEKSELL VANTAGE ARC SYSTEM
07340201501337 - Leksell Vantage Stereotactic System2024-08-14 FirmFix™ 5
07340201501290 - Leksell Vantage Stereotactic System2024-08-13 FirmFix™ 3
07340201501313 - Leksell Vantage Stereotactic System2024-08-13 FirmFix™ 4

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