FDA.reportPublic FDA data

S.T. Genesis

Primary DI
08908006064120
Brand
S.T. Genesis
Company
NEUROSTIMULATION MEDTECH PRIVATE LIMITED
Model
S.T. Genesis
Device description
S.T. Genesis
Published
2024-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZRPercutaneous Nerve Stimulator For Opioid WithdrawalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006064120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006064120089080060641208908006064120

GMDN Terms#

Term, Definition table
TermDefinition
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulatorA body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
916731981
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908006064311Morph DeviceMorph Device2026-05-22
08908006064328POSP DevicePOSP Device2026-05-22
08908006064199Primary Relief Primary Relief 2026-03-16
08908006064205OpiEaseOpiEase2026-03-16
08908006064212NociRelief NociRelief 2026-03-16
08908006064229GiCalmGiCalm2026-03-16
08908006064236NS100NS1002026-03-16
08908006064243First Relief v1First Relief v12026-03-16
08908006064267ANSiSTIM - PP ANSiSTIM - PP 2026-03-16
08908006064281ANSiSTIM-PP ANSiSTIM-PP 2026-03-16
08908006064250NEUMONANEUMONA2025-08-18
08908006064168POSP Device POSP Device 2025-05-19
08908006064090NeuroSolutions 100NeuroSolutions 1002024-07-19
08908006064106OpiReliefOpiRelief2024-07-19
08908006064113Morph DeviceMorph Device2024-07-20
08908006064083Drug Relief v1Drug Relief v12026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064311Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-05-22
08908006064083Drug Relief v1NEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
08908006064205OpiEaseNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
00850052017552Sparrow AscentSpark Biomedical Inc.PZR2026-02-02
08908006064113Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064106OpiReliefNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-19
00850052017019Sparrow Ascent Earpiece, RightSpark Biomedical Inc.PZR2023-09-07
00850052017033Sparrow Ascent Replacement KitSpark Biomedical Inc.PZR2023-09-07
00850052017040Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396948Sparrow Ascent Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396955Sparrow Ascent Patient ControllerSpark Biomedical Inc.PZR2023-09-07
00860005396962Sparrow Ascent Earpiece, LeftSpark Biomedical Inc.PZR2023-09-07
00860005396979Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00860005396986Sparrow Ascent Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
B960NSS200NSS-2 BridgeNeuraxis, Inc.PZR2021-02-12
B960NSS2001NSS-2 BridgeInnovative Health Solutions, IncPZR2021-02-12
B327NSS200NSS-2KEY ELECTRONICS, INC.PZR2018-03-30