DEVICE: Alpine BioMed (05704736004091)
Device Identifier (DI) Information
Alpine BioMed
8015A0012
Not in Commercial Distribution
Alpine Biomed ApS
8015A0012
Not in Commercial Distribution
Alpine Biomed ApS
CLAVIS, DEVICE COMPLETE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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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? |
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35723 | Nerve-locating system |
An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GWL | Amplifier, Physiological Signal |
BXN | Stimulator, Nerve, Battery-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K062478 | 000 |
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
1719f048-0e8d-473b-86aa-5b202d081c5f
April 29, 2020
5
August 24, 2016
April 29, 2020
5
August 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 |
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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
[?]
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