AccessGUDID - DEVICE: POSP Device (08908006064168)

GUDID

Device Identifier (DI) Information

Brand Name: POSP Device
Version or Model: POSP Device
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYANSYS INDIA PRIVATE LIMITED

Primary DI Number: 08908006064168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 916731981 *Terms of Use

Device Description: POSP Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c6bf2c7-ad66-4efa-8ea6-e20383e47ebb
Public Version Date: May 27, 2025
Public Version Number: 1
DI Record Publish Date: May 19, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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