DEVICE: AS univation® XF (04046964053610)

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Device Identifier (DI) Information

AS univation® XF
NO184Z
NO184Z
Aesculap AG
04046964053610
GS1
1
AS UNIVATION XF FEMUR CEMENTED F5 RM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Uncoated unicondylar knee femur prosthesis A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement.
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FDA Product Code

[?]
Product Code Product Code Name
HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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

[?]
Size Type Text
Device Size Text, specify: Shape / Form : right medial
Device Size Text, specify: Implant Fixation : cemented
Device Size Text, specify: Figure / Size : F5
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)229-3002
setworld_orders@aesculap.com
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