Primary Device ID | 07340048304689 |
NIH Device Record Key | cde2a552-c03c-4a62-83a3-e14e55f3a737 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Leksell Vantage Stereotactic System |
Version Model Number | 1054751 |
Company DUNS | 507772663 |
Company Name | Elekta Instrument 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07340048304689 [Primary] |
HAW | Neurological stereotaxic Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
[07340048304689]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-22 |
Device Publish Date | 2018-09-21 |
07340048311335 | Leksell Vantage Key |
07340048311281 | Leksell Vantage™ Arc Tray |
07340048311151 | Leksell Vantage™ Support Arc |
07340048305167 | Leksell Vantage™ Head Frame |
07340048304887 | ARC CARRIER |
07340048304870 | GUIDE SLIDE |
07340048304863 | STOP SLIDE |
07340048304856 | ARC COMPLETE |
07340048304849 | SUPPORT ARC COMPLETE |
07340048304832 | ARC SUPPORT LEFT |
07340048304825 | ARC SUPPORT RIGHT |
07340048304818 | ARC SLIDE LEFT |
07340048304801 | ARC SLIDE RIGHT |
07340048304795 | ARC Y SCALE RIGHT |
07340048304788 | ARC Y SCALE LEFT |
07340048304757 | MRI PLATE ASSEMBLY RIGHT |
07340048304726 | MRI PLATE ASSEMBLY LEFT |
07340048304719 | MRI FIDUCIAL ARCH POSTERIOR |
07340048304702 | MRI FIDUCIAL ARCH ANTERIOR |
07340048304696 | CROSS HAIR TARGET RING |
07340048304689 | CROSS HAIR TARGET CROSS |
07340048304672 | STARBURST RADIOLUSCENT ADAPTER |
07340048304665 | STARBURST ADAPTER |
07340048304658 | RADIOLUSCENT ADAPTER |
07340048304412 | Leksell Vantage Head Frame Positioning Band |
07340048304405 | LEKSELL VANTAGE CROSS-HAIRS |
07340048304399 | LEKSELL VANTAGE ARC SYSTEM |
07340048304382 | LEKSELL VANTAGE OR ADAPTER |
07340048304375 | MRI FIDUCIAL BOX |
07340048304368 | MRI COIL ADAPTER UPPER STOP |
07340048304351 | MRI COIL ADAPTER UNIVERSAL |
07340048304344 | MRI COIL ADAPTER LOWER STOP |
07340048304337 | MRI COIL ADAPTER LARGE |
07340048311342 | FirmFix™ Ruler |
07340048304290 | FirmFix™ 5 |
07340048304276 | FirmFix™ 4 |
07340048304252 | FirmFix™ 3 |
07340048304238 | FirmFix™ 2 |
07340048304214 | FirmFix™ 1 |
07340048304207 | Leksell Vantage™ Head Frame |
07340048311625 | VANTAGE STARBURST 3/8 |
07340048311601 | VANTAGE RADIOLUCENT STARBURST 1/2" |
07340048311472 | LEKSELL VANTAGE CT INTERFACE |
07340048311458 | Vantage™ Frame Holder extension |
07340048311434 | LEKSELL VANTAGE CT FIDUCIAL BOX |
07340048311373 | LEKSELL VANTAGE FRAME HOLDER |
07340048311991 | MRI COIL ADAPTER LARGE |
07340048311977 | MRI COIL ADAPTER UPPER STOP |
07340048311953 | MRI COIL ADAPTER LOWER STOP |
07340048312011 | MRI COIL ADAPTER UNIVERSAL |