Alignment Arm 53089-03

GUDID 04056481140120

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
Primary Device ID04056481140120
NIH Device Record Key40bd62c9-80a7-44a9-b78c-4e4405ff65dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignment Arm
Version Model Number53089-03
Catalog Number53089-03
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481140120 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2019-05-22

Devices Manufactured by Brainlab AG

04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE2024-01-04
04056481144845 - Automatic Registration iMRI2023-11-28 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 IMRI2023-10-24
04056481145101 - Automatic Registration2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA
04056481143138 - Drill Bit Cranial 2.4/4.02023-09-26
04056481143145 - Drill Bit Cranial 2.1/4.02023-09-26

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