Cranial Navigation System Navigation

GUDID 04056481141356

Brainlab AG

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system
Primary Device ID04056481141356
NIH Device Record Keyf679b8ab-f76e-4635-b082-fabf32b3e1ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Navigation System Navigation
Version Model Number4.0
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481141356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-05
Device Publish Date2020-07-28

Devices Manufactured by Brainlab AG

04056481144753 - Drill Guide Array2024-06-12
04056481144760 - Drill Guide Depth Control (60 - 100 mm)2024-06-12
04056481144777 - Drill Guide Depth Control (0 - 60 mm)2024-06-12
04056481144784 - Drill Guide Tube (4.5 mm)2024-06-12
04056481144791 - Drill Guide Tube (3.2 mm)2024-06-12
04056481144807 - Drill Guide Tube (2.6 mm)2024-06-12
04056481144814 - Drill Guide Tube (2.4 mm)2024-06-12
04056481144821 - Drill Guide Tube (2.0 mm)2024-06-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.