DEVICE: INSTRUMENT (07613327212303)

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Device Identifier (DI) Information

INSTRUMENT
2107-1016
2107-1016
Howmedica Osteonics Corp.
07613327212303
GS1
1
FLEXIBLE DRIVER SHAFT
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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
Surgical screwdriver, reusable A tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. Some types may include a torque-measuring gauge. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWL Prosthesis, hip, hemi-, femoral, metal
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
HWC Screw, fixation, bone
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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