Em Instrument Reference 18099-05A

GUDID 04056481004873

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481004873
NIH Device Record Keycd44592a-bfb3-4a84-981b-b51f816cbd65
Commercial Distribution StatusIn Commercial Distribution
Brand NameEm Instrument Reference
Version Model Number18099-05A
Catalog Number18099-05A
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481004873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481004873]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


[04056481004873]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

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04056481146320 - Alignment Software Spine2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
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

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