DEVICE: INSTRUMENT (07613327208184)

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Device Identifier (DI) Information

INSTRUMENT
1030-1200
1030-1200
Howmedica Osteonics Corp.
07613327208184
GS1
1
TRIDENT ALL-POLY FLEXIBLE DRILL SHAFT
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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
Fluted surgical drill, reusable A 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, it is usually inserted 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 reusable device.
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FDA Product Code

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Product Code Product Code Name
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWL Prosthesis, hip, hemi-, femoral, metal
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
HWC Screw, fixation, bone
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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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
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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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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