DEVICE: POSP Device (08908006064168)

Device Identifier (DI) Information

POSP Device
POSP Device
In Commercial Distribution

DYANSYS INDIA PRIVATE LIMITED
08908006064168
GS1

1
916731981 *Terms of Use
POSP Device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K213188 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0c6bf2c7-ad66-4efa-8ea6-e20383e47ebb
May 27, 2025
1
May 19, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
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Customer Contact

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No Customer Contact currently defined
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