DEVICE: NA (04546540905321)

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Device Identifier (DI) Information

NA
0407260000
0407260000
STRYKER CORPORATION
04546540905321
GS1
1
Percutaneous Discectomy Probe
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Diskectomy system, percutaneous, automatic An automated system intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. This system is used to resect and aspirate the nucleus pulposus in one step, eliminating the need for repeated insertion of the nucleotome. It provides an alternative to surgical diskectomy and is typically carried out under local anaesthesia. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HRX ARTHROSCOPE
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Needle Gauge: 17.0 Gauge
Length: 9.0 Inch
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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