StimRouter User Kit

GUDID 00815962020030

External Pulse Transmitter (EPT)

BIONESS INC.

Analgesic PENS system probe, single-use
Primary Device ID00815962020030
NIH Device Record Keyba2d7f00-9a90-4a0d-8959-4230fb82f98a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimRouter User Kit
Version Model NumberST2-5000
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-12-19

On-Brand Devices [StimRouter User Kit]

00815962020030External Pulse Transmitter (EPT)
00815962021464External Electrical Field Conductor

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