DEVICE: Corin Bipolar Prosthesis (05055196947436)

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Device Identifier (DI) Information

Corin Bipolar Prosthesis
211.303
211.303
CORIN LTD
05055196947436
GS1
1
Bi-Polar Press
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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 implant/instrument assembling device A non-sterile device designed to assemble the component parts of an orthopaedic implant or surgical instrument during a surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It typically consists of a manually-operated press made of metal [e.g., steel, titanium (Ti)] and/or carbon fibre, and may include accessories such as exchangeable gripping devices (holders), an impactor head, and a torque wrench. 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
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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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
August 17, 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

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Yes
No
No
No
No CLOSE

Customer Contact

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+441285659866 2118
rachel.king@coringroup.com
+441285659866 2203
lucinda.gerber@coringroup.com
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