Skull Reference Array 52120E

GUDID 04056481002497

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481002497
NIH Device Record Key37f98e17-f0c7-4d59-bbbe-66c96c10c054
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkull Reference Array
Version Model Number52120E
Catalog Number52120E
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481002497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481002497]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-12
Device Publish Date2016-09-15

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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