Leksell Gamma Knife Esprit

GUDID 07340201501139

Teletherapy radionuclide system, conventional

Primary Device ID	07340201501139
NIH Device Record Key	f07ed625-081f-4ca0-a62c-84df9ce58627
Commercial Distribution Status	In Commercial Distribution
Brand Name	Leksell Gamma Knife Esprit
Version Model Number	1110200
Company DUNS	353272181
Company Name	Elekta Solutions AB
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07340201501139 [Primary]

IWB	System, Radiation Therapy, Radionuclide

Steralize Prior To Use	false
Device Is Sterile	false

07340201503782 - AQUA	2025-12-18 AQUA V3.3 Machine QA Software
07340201502273 - Leksell Stereotactic System	2025-09-25 Post Insulated anterior
07340201503317 - Leksell Stereotactic System	2025-09-25 Instrument Screwdriver, Double
07340201502440 - Leksell Stereotactic System	2025-09-25 Ear Plug Holders
07340201502921 - Leksell Stereotactic System	2025-09-25 Slotted Front Piece
07340201502914 - Leksell Stereotactic System	2025-09-25 Post Insulated posterior long
07340201502488 - Leksell Stereotactic System	2025-09-25 Curved Front Piece
07340201503287 - Leksell Stereotactic System	2025-09-25 Insulated Curved Post