OpiEase

GUDID 08908006064205

OpiEase

DYANSYS INDIA PRIVATE LIMITED

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Primary Device ID08908006064205
NIH Device Record Keyce3e1803-d01f-4302-b33a-09104cd4ae6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpiEase
Version Model NumberOpiEase
Company DUNS916731981
Company NameDYANSYS INDIA PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108908006064205 [Primary]

FDA Product Code

PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-24
Device Publish Date2026-03-16

Devices Manufactured by DYANSYS INDIA PRIVATE LIMITED

08908006064083 - Drug Relief v12026-03-24 Drug Relief v1
08908006064199 - Primary Relief 2026-03-24 Primary Relief
08908006064205 - OpiEase2026-03-24OpiEase
08908006064205 - OpiEase2026-03-24 OpiEase
08908006064212 - NociRelief 2026-03-24 NociRelief
08908006064229 - GiCalm2026-03-24 GiCalm
08908006064236 - NS1002026-03-24 NS100
08908006064243 - First Relief v12026-03-24 First Relief v1
08908006064267 - ANSiSTIM - PP 2026-03-24 ANSiSTIM - PP

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