DEVICE: INSTRUMENT (07613327179293)

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Device Identifier (DI) Information

INSTRUMENT
6541-4-809
6541-4-809
Howmedica Osteonics Corp.
07613327179293
GS1
1
HEADLESS PIN DRIVER TRIATHLON INSTRUMENTS
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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 power tool system handpiece, reaming, pneumatic A hand-held, pneumatically-powered device intended to provide torque specifically for reaming during surgical procedures. The device typically includes a chuck or collet to grip a reamer (e.g., an orthopaedic intramedullary canal reamer), and it usually provides a high torque for heavy reaming; the reaming endpiece is not included. The device is usually cannulated to allow for use of a guidewire. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
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

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No Customer Contact currently defined
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