DEVICE: Universal Neuro 2, Universal Neuro 3 (04546540684967)

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Device Identifier (DI) Information

Universal Neuro 2, Universal Neuro 3
60-12396
60-12396
Stryker Leibinger GmbH & Co. KG
04546540684967
GS1
1
DRILL, WL 6MM, TPS SHAFT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Fluted surgical drill, single-use, non-sterile A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in various sizes. This is a single-use device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 87.0 Millimeter
Length: 6.0 Millimeter
Device Size Text, specify: Diameter: 1.2 Millimeter
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Device Status

In Commercial Distribution
August 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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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