Evala nerve stimulator

GUDID 10860013827103

Handheld Single-use Surgical Nerve Stimulator

Epineuron Technologies Inc.

Nerve-locating system
Primary Device ID10860013827103
NIH Device Record Keyb2e241b3-4e9e-4082-8597-5b2faea8fb08
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvala nerve stimulator
Version Model NumberEPNR002
Company DUNS208240384
Company NameEpineuron Technologies Inc.
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

Customer Support Contacts

Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com
Phone9052060466
Emailinfo@epineurontech.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013827106 [Primary]
GS110860013827103 [Package]
Contains: 00860013827106
Package: shelf box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNStimulator, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-25
Device Publish Date2026-03-17

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.