DEVICE: NA (04546540350886)
Device Identifier (DI) Information
NA
6001-231-000
In Commercial Distribution
6001-231-000
Stryker Leibinger GmbH & Co. KG
6001-231-000
In Commercial Distribution
6001-231-000
Stryker Leibinger GmbH & Co. KG
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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 |
---|---|
Stereotactic surgery system probe, reusable | A long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Special Storage Condition, Specify: 3V |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a7a2f3dc-298a-4ebc-ad85-6a5ff2864788
March 29, 2018
2
August 24, 2016
March 29, 2018
2
August 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined