Paragon Super Stim Electrodes 442722

GUDID 00866811000222

PARAGON REHAB SUPPLIES LLC

Transcutaneous electrical stimulation electrode
Primary Device ID00866811000222
NIH Device Record Key4a6ef780-6d0b-45ef-b336-74d36391b756
Commercial Distribution StatusIn Commercial Distribution
Brand NameParagon Super Stim Electrodes
Version Model Number2" x 2" Foam Electrodes
Catalog Number442722
Company DUNS080255394
Company NamePARAGON REHAB SUPPLIES LLC
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com
Phone505-881-2390
EmailJennifer@paragonrehabsupplies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100866811000222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-13

On-Brand Devices [Paragon Super Stim Electrodes]

008668110002392" x 4" Foam Electrodes
008668110002222" x 2" Foam Electrodes
008668110002152" x 4" Cloth Electrodes

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