DEVICE: Trident (04546540259936)

Device Identifier (DI) Information

Trident
625-0T-36I
In Commercial Distribution
625-0T-36I
Howmedica Osteonics Corp.
04546540259936
GS1

1
058311945 *Terms of Use
Alpha Code I
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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
Ceramic acetabular liner A sterile implantable inner 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 ceramic material (e. g alumina).
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FDA Product Code

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Product Code Product Code Name
MRA Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000013 001
P000013 002
P000013 003
P000013 004
P000013 005
P000013 006
P000013 008
P000013 009
P000013 010
P000013 011
P000013 012
P000013 015
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Degree: 0.0 Degree
Lumen/Inner Diameter: 36.0 Millimeter
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Device Record Status

5b68d2b0-6aa9-46df-9ed6-1051ed31abc5
November 12, 2018
4
October 09, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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