Primary Device ID | 04056481142650 |
NIH Device Record Key | f8dbce72-f522-4e7e-b354-ef94f6d09e32 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cranial IGS System - Ultrasound Navigation |
Version Model Number | 1.1 |
Company DUNS | 314482980 |
Company Name | Brainlab AG |
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 | false |
OTC Over-The-Counter | false |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com | |
Phone | +18005975911 |
us.support@brainlab.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04056481142650 [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 | 2021-01-28 |
Device Publish Date | 2021-01-20 |
04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE | 2024-01-04 |
04056481144845 - Automatic Registration iMRI | 2023-11-28 Automatic Registration iMRI provides an automatic image registration for cranial indications. |
04056481145606 - HEX SCREWDRIVER T-HANDLE (2.5 MM) | 2023-10-27 |
04056481145217 - DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS) | 2023-10-25 |
04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI | 2023-10-24 |
04056481145101 - Automatic Registration | 2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA |
04056481143138 - Drill Bit Cranial 2.4/4.0 | 2023-09-26 |
04056481143145 - Drill Bit Cranial 2.1/4.0 | 2023-09-26 |