DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE

GUDID 04056481141660

Brainlab AG

Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted
Primary Device ID04056481141660
NIH Device Record Keye030f358-9b0b-4174-ab8b-1f06f132dae0
Commercial Distribution Discontinuation2023-05-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE
Version Model Number56101
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS104056481141660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-01-04
Device Publish Date2023-01-11

Devices Manufactured by Brainlab AG

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04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE2024-01-04
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
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