DEVICE: PRIMA (08033390201704)

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Device Record History
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Device Identifier (DI) Information
PRIMA
1357.14.038
In Commercial Distribution
1357.14.038
LIMACORPORATE SPA
08033390201704
GS1

1
432066322 *Terms of Use
PRIMA - Short Stem #6
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48090 Press-fit shoulder humeral stem prosthesis
A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural humerus to achieve a mechanical interlock without the use of bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PHX Shoulder Prosthesis, Reverse Configuration
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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: #6
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Device Record Status
785261ab-ec0e-4bfc-8f84-369c306af353
March 18, 2024
3
March 15, 2022
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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
No Customer Contact currently defined
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