DEVICE: DELTA (04546540338150)

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Device Identifier (DI) Information

DELTA
70-76003
70-76003
Stryker Leibinger GmbH & Co. KG
04546540338150
GS1
1
DELTA BATH STERILIZATION CORD
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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 water bath system An assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) water bath with temperature-regulating controls, a thermometer/thermostats, a timer, a sterilizable water holder (a pan or a tray), and a sterility cover that is placed over the bath to maintain the integrity of the sterile surgical field. The implants are submerged in sterile water or saline solution and typically heated to approximately 60-70? Celsius.
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FDA Product Code

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Product Code Product Code Name
IRQ UNIT, HEATING, POWERED
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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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
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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
January 11, 2017

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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
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Customer Contact

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No Customer Contact currently defined
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