DEVICE: AGILON® extension piece (04048844330705)

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Device Record History
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Device Identifier (DI) Information
AGILON® extension piece
38210075
In Commercial Distribution

implantcast GmbH
04048844330705
GS1

1
324369826 *Terms of Use
No description.
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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?
61006 Humeral stem extension prosthesis
A sterile implantable component of a total shoulder prosthesis intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus (e.g., due to trauma or tumour) to achieve the additional length required for connection to a humeral body. It is a modular arrangement of interlocking parts so the length can be configured intraoperatively. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
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: Size: 7.5mm
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Device Record Status
9440a906-b4ad-4884-b7c0-85dc397d5509
November 26, 2020
1
November 18, 2020
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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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