DEVICE: PROFESS (07613252727019)

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Device Identifier (DI) Information

PROFESS
6001-410-000
6001-410-000
Stryker Leibinger GmbH & Co. KG
07613252727019
GS1
1
PROFESS(TM) STRAIGHT SUCTION
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Device Characteristics

MR Unsafe
No
No
Yes
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, single-use A long, sterile, slender, rod-like device made of metal and/or plastic, 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 single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
PGW Ear, Nose, and Throat Stereotaxic Instrument
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 4 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Special Storage Condition, Specify: TRANSPORT:10-90%/-20-50¿C/50-106KPA
Special Storage Condition, Specify: 5V
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 24, 2016

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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
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Secondary DI

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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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