DEVICE: INSTRUMENT (07613327212372)

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Device Identifier (DI) Information

INSTRUMENT
2107-3360
2107-3360
Howmedica Osteonics Corp.
07613327212372
GS1
1
DRILL BIT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
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
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWL Prosthesis, hip, hemi-, femoral, metal
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
HWC Screw, fixation, bone
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
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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: 60.0 Millimeter
Device Size Text, specify: Diameter: 3.3 Millimeter
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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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