DEVICE: n.a. (04048551271087)

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Device Identifier (DI) Information

n.a.
40800120

Karl Storz GmbH & Co. KG
04048551271087
GS1
1
Optical Tool Tracker
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Optical surgical navigation device tracking system instrument localizer A non-sterile component of an optical surgical navigation device tracking system intended to track the position/movement of an optically navigated surgical instrument (e.g., a stereotactic surgery system probe) during computer assisted surgery (CAS). It is attached to the navigated surgical instrument and contains reflective spheres designed to reflect light to a tracking camera [e.g., infrared (IR) light camera]; it is typically made of titanium (Ti). This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological stereotaxic Instrument
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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