DEVICE: Alpine Biomed (05704736017558)
Device Identifier (DI) Information
Alpine Biomed
9031E0144
Not in Commercial Distribution
Alpine Biomed ApS
9031E0144
Not in Commercial Distribution
Alpine Biomed ApS
Hand-Held Stimulating Electrodes
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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35729 | Diagnostic peripheral nerve electrical stimulation system |
An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GWF | Stimulator, Electrical, Evoked Response |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K944547 | 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
2d9422d1-d3ce-47ac-8f92-566b68ee5c48
April 29, 2020
4
October 13, 2016
April 29, 2020
4
October 13, 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
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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
[?]
No Customer Contact currently defined