StimRouter Implantable Kit

GUDID 00815962020016

StimRouter Implantable Lead

BIONESS INC.

Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use Analgesic PENS system probe, single-use
Primary Device ID00815962020016
NIH Device Record Key17f6e99a-4a74-49d5-a8f9-268bd1a42f1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimRouter Implantable Kit
Version Model NumberST2-1000
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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 Dimensions

Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter
Length15 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

[00815962020016]

Ethylene Oxide

Device Entry Metadata

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

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