DEVICE: BiMobile Dual Mobility System - Instruments (04026575241903)
Device Identifier (DI) Information
BiMobile Dual Mobility System - Instruments
130-311/05
In Commercial Distribution
WALDEMAR LINK GmbH & Co. KG
130-311/05
In Commercial Distribution
WALDEMAR LINK GmbH & Co. KG
Orthopaedic chisel - BiMobile Dual Mobility System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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44597 | Orthopaedic cement extractor, manual |
A hand-held manual surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other manually-operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LXH | Orthopedic manual surgical instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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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No Device Sizes |
Device Record Status
d9c07c14-09f8-4468-9f8c-567e998aa426
February 25, 2025
2
December 19, 2022
February 25, 2025
2
December 19, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined