Sterilization Tray Robotic Cranial Biopsy for Cirq

GUDID 04056481141639

Brainlab AG

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID04056481141639
NIH Device Record Keyecf29859-40ac-435d-92dd-c1bbdec4cedd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilization Tray Robotic Cranial Biopsy for Cirq
Version Model Number52334
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104056481141639 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-29
Device Publish Date2020-10-21

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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