DEVICE: NA (04546540364623)

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Device Identifier (DI) Information

NA
6001-200-010
6001-200-010
Stryker Leibinger GmbH & Co. KG
04546540364623
GS1
1
SKULL POST
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Surgical navigation device tracking system cranial localizer holder A non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended for short-term (= 30 days) stable fixation of a localizer/tracker to the skull during computer assisted surgery (CAS). It is made of titanium (Ti) and typically has components for fixation onto the skull (e.g., self-drilling screws) and for attachment of the localizer/tracker that allow rotation (e.g., connecting pins). This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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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
Length: 2.0 Millimeter
Device Size Text, specify: Diameter: 1.0 Millimeter
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Device Status

In Commercial Distribution
August 24, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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