DEVICE: PRIMA (08033390244725)

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Device Record History
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Device Identifier (DI) Information
PRIMA
9013.67.162
In Commercial Distribution
9013.67.162
LIMACORPORATE SPA
08033390244725
GS1

1
432066322 *Terms of Use
PRIMA - Metaphyseal Size Ring #2
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46479 Surgical implant template, reusable
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHX Shoulder Prosthesis, Reverse Configuration
KWS Prosthesis, Shoulder, Semi-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
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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: #2
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Device Record Status
68b6828c-ea6d-40c2-8c35-94d3ac4f4b26
February 07, 2024
3
December 21, 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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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