DEVICE: System 12 (04546540269676)

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Device Identifier (DI) Information

System 12
6302-5-064
6302-5-064
Howmedica Osteonics Corp.
04546540269676
GS1
1
0degrees Polyethylene Insert
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Non-constrained polyethylene acetabular liner A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
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FDA Product Code

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
Device Size Text, specify: Degree: 0.0 Degree
Lumen/Inner Diameter: 28.0 Millimeter
Device Size Text, specify: Acetabular Insert: P4
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Device Status

In Commercial Distribution
September 24, 2015

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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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