DEVICE: RemB (07613154945801)

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Device Identifier (DI) Information

RemB
6400062000
6400062000
STRYKER CORPORATION
07613154945801
GS1
1
Electric Wiredriver
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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 power tool system handpiece, wire-driving, rechargeable battery-powered A battery-powered, drill-like, machine intended to be used for the sole purpose of driving in orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different widths that are pointed for self-drilling), into bone for the restoration of bones. This device will typically have a special gripping collet for rapid repositioning of the hold on the wire as it is fed into the bone. A rechargeable battery pack is attached to this device to provide the low-voltage electrical power. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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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
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
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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
September 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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No
Yes
No
No
No CLOSE

Customer Contact

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