DEVICE: SMR Shoulder (08033390214599)

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Device Record History
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Device Identifier (DI) Information
SMR Shoulder
9013.79.583
In Commercial Distribution
9013.79.583
LIMACORPORATE SPA
08033390214599
GS1

1
432066322 *Terms of Use
SMR Shoulder - Glenosph. Dia. 42-Ecc.42 Extract. Insert
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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?
12696 Orthopaedic inorganic implant inserter/extractor, reusable
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Active false
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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
PHX Shoulder Prosthesis, Reverse Configuration
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, 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: Dia. 42-Ecc.42
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Device Record Status
08811bdf-3bfb-4d19-9eb9-d618b749dfa2
September 11, 2024
4
March 17, 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

[?]
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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