DEVICE: SMR System (08033390274166)

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Device Record History
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Device Identifier (DI) Information
SMR System
1322.09.446
In Commercial Distribution
1322.09.446
LIMACORPORATE SPA
08033390274166
GS1

1
432066322 *Terms of Use
SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 6mm
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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?
48088 Stem-fixed metallic humeral head prosthesis
An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K161476 000
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: Dia. 44 mm H. 13 mm Eccentrical 6mm
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Device Record Status
c8332137-6681-41d7-b0cd-146031ca01f9
March 06, 2025
2
February 27, 2024
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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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