DEVICE: POSP Device (08908006064168)
Device Identifier (DI) Information
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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67067 | Analgesic periauricular vagus nerve percutaneous electrical stimulator |
A body-worn electronic device intended for vagus nerve stimulation (VNS) applied close to auricular peripheral nerves to achieve remote pain relief mediated by central nervous system (CNS) pathways and structures [e.g., brainstem activation]; it may be used to relieve chronic pain (e.g., back pain, cervical syndrome, migraine) or acute pain (e.g., post-operative pain). It consists of an electrical pulse generator with minimally-invasive electrodes intended to be applied to the auricle by a clinical professional. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K213188 | 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
0c6bf2c7-ad66-4efa-8ea6-e20383e47ebb
May 27, 2025
1
May 19, 2025
May 27, 2025
1
May 19, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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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