Bioness L300 Go Hydrogel Electrodes

GUDID 00815962020078

Hydrogel Electrode Set

BIONESS INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00815962020078
NIH Device Record Keyc835a12a-ba40-4aa6-b557-d8dee3e2c8ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioness L300 Go Hydrogel Electrodes
Version Model NumberLG3-5F00
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

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
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, muscle, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-18
Device Publish Date2018-08-13

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