CRANIAL 4PI HEADREST INLAY STANDARD 2PCS

GUDID 04056481144203

Brainlab AG

Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system
Primary Device ID04056481144203
NIH Device Record Key143091d6-a576-49ac-8847-612c3b3c205e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIAL 4PI HEADREST INLAY STANDARD 2PCS
Version Model Number43446A
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481144203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

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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