DEVICE: DJO SURGICAL (00888912076791)

Device Identifier (DI) Information

DJO SURGICAL
411-00-144
In Commercial Distribution

Encore Medical, L.P.
00888912076791
GS1

1
154074504 *Terms of Use
HEAD, UNIPOLAR, MODULAR, ENCORE SIZE44
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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
Metallic femoral head prosthesis A sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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FDA Product Code

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Product Code Product Code Name
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973614 000
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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
No Device Sizes
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Device Record Status

820f6d07-d114-4195-b397-2ea193a23037
October 09, 2018
4
August 07, 2017
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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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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