Primary Device ID | 07340048311731 |
NIH Device Record Key | 9e6ff044-2a4e-45cf-ad88-d8d076d07e46 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leksell Gamma Knife Perfexion/Icon |
Version Model Number | 1075233 |
Company DUNS | 507772663 |
Company Name | Elekta Instrument AB |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com | |
Phone | +1(855)693-5358 |
info.america@elekta.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07340048311731 [Primary] |
IWB | System, radiation therapy, radionuclide |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-05 |
Device Publish Date | 2021-03-28 |
07340048309516 | FRAME FIXATION ADAPTER |
07340048307963 | FRAME FIXATION ADAPTER |
07340048306591 | CC EXCHANGE TOOL |
07340048306553 | CLEARENCE CHECK TOOL |
07340048306546 | QA FILM HOLDER |
07340048306522 | FRAME CAP |
07340048306454 | DOSIMETRY PHANTOM |
07340048306188 | RADIATION PHANTOM WITH CASSETTES |
07340048305617 | PHANTOM ADAPTER COMPLETE |
07340048306447 | LEKSELL GAMMA KNIFE DOSIMETRY PHANTOM |
07340048305112 | POST INSULATED LONG POSTERIOR |
07340048311762 | Dosimetry Phantom Vantage LGK |
07340048311755 | QA TOOL VANTAGE LGK |
07340048311731 | Dosimetry Phantom Vantage Base |
07340048311700 | FILM HOLDER VANTAGE LGK |