DEVICE: SMR Shoulder (08033390156967)

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Device Record History
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Device Identifier (DI) Information
SMR Shoulder
1352.15.011
In Commercial Distribution
1352.15.011
LIMACORPORATE SPA
08033390156967
GS1

1
432066322 *Terms of Use
SMR Shoulder - 140° Reverse humeral body
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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?
60511 Reverse shoulder prosthesis body
A sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PHX Shoulder Prosthesis, Reverse Configuration
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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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: 140°
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Device Record Status
1b727423-b069-49ee-a8f4-4e4b30182a69
October 14, 2024
2
January 15, 2021
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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

[?]
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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