DEVICE: INSTRUMENT (07613327221893)

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Device Identifier (DI) Information

INSTRUMENT
6278-9-414
6278-9-414
Howmedica Osteonics Corp.
07613327221893
GS1
1
RESTORATION MODULAR INST SYS BOWED DISTAL STEM TRIAL
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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
Femoral stem trial prosthesis A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems and trial necks. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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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: 217.0 Millimeter
Device Size Text, specify: Diameter: 14.0 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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