DEVICE: REUNION (07613327100730)
Device Identifier (DI) Information
REUNION
5901-IC-4010
In Commercial Distribution
5901-IC-4010
Stryker Trauma SA
5901-IC-4010
In Commercial Distribution
5901-IC-4010
Stryker Trauma SA
Humeral Insert Trial - Constrained
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58784 | Humeral head prosthesis trial, reusable |
A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter: 40.0 Millimeter |
Device Size Text, specify: Thickness: 10.0 Millimeter |
Device Record Status
c02e8d5c-e44d-4a6d-adbe-4b2c75d0f8a0
February 07, 2019
3
September 24, 2016
February 07, 2019
3
September 24, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined