Primary Device ID | 07340048311793 |
NIH Device Record Key | ace932fc-fb13-4aed-bfd5-2140c85f82d8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leksell Stereotactic System Neurosurgical Instruments |
Version Model Number | 1075647 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07340048311793 [Primary] |
HAW | Neurological stereotaxic Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-08 |
Device Publish Date | 2021-05-31 |
07340048311892 - Leksell Vantage Stereotactic System | 2022-11-14 ARC CARRIER |
07340048311793 - Leksell Stereotactic System Neurosurgical Instruments | 2021-06-08INSERTION RULER |
07340048311793 - Leksell Stereotactic System Neurosurgical Instruments | 2021-06-08 INSERTION RULER |
07340048312011 - Leksell Vantage Stereotactic System | 2021-04-07 MRI COIL ADAPTER UNIVERSAL |
07340048311700 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 FILM HOLDER VANTAGE LGK |
07340048311731 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 Dosimetry Phantom Vantage Base |
07340048311755 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 QA TOOL VANTAGE LGK |
07340048311762 - Leksell Gamma Knife Perfexion/Icon | 2021-04-05 Dosimetry Phantom Vantage LGK |
07340048311779 - Leksell Gamma Knife Icon | 2021-04-05 LEKSELL VANTAGE ADAPTER LGK |