ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)

GUDID 04056481145521

Brainlab AG

Neurosurgical ultrasound navigation system optical tracking unit
Primary Device ID04056481145521
NIH Device Record Key61b2d354-2a7c-4c1e-b3f0-ac8c9b9252ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)
Version Model Number41860-5E
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481145521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481145521]

Moist Heat or Steam Sterilization


[04056481145521]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-23
Device Publish Date2025-06-13

Devices Manufactured by Brainlab AG

04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)2025-06-23
04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)2025-06-23
04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) 2025-06-23
04056481145828 - Microscope Navigation 2025-06-19
04056481143985 - Mixed Reality Spine Navigation2025-06-09
04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26
04056481141677 - Cirq Robotic Disposable Kinematic Unit2025-03-26
04056481125967 - Patient Mask Set 2025-03-18
04056481142698 - Frameless SRS MASK SET CRANIAL2025-03-18

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