DEVICE: INSTRUMENT (07613327208047)

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Device Identifier (DI) Information

INSTRUMENT
1020-2100
1020-2100
Howmedica Osteonics Corp.
07613327208047
GS1
1
ACCOLADE C DISTAL SIZER
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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
Orthopaedic graft sizer A non-sterile surgical instrument that contains a series of holes of varying diameters intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to determine the size of a graft to be implanted. It is used in vitro [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the holes drilled into the site (e.g., distal femur) for acceptance of the new graft. The device may be made of polysulfone. 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
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWL Prosthesis, hip, hemi-, femoral, metal
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
HWC Screw, fixation, bone
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
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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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