DEVICE: SMR Shoulder (08033390199063)

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Device Record History
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Device Identifier (DI) Information
SMR Shoulder
1365.54.821
In Commercial Distribution
1365.54.821
LIMACORPORATE SPA
08033390199063
GS1

1
432066322 *Terms of Use
SMR Shoulder - Reverse Liner Retentive +6 mm Dia. 40 mm - LIMAVIT
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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?
48092 Polyethylene reverse shoulder prosthesis cup
A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.
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
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K220792 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. 40 mm, Retentive +6mm
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Device Record Status
2bc3b3f3-3e76-48d5-a048-fd1a4f130ba0
July 11, 2022
1
July 02, 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

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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