Paragon Super Stim Electrode 442522

GUDID 00866811000208

PARAGON REHAB SUPPLIES LLC

Transcutaneous electrical stimulation electrode
Primary Device ID00866811000208
NIH Device Record Keybffdfa6e-193a-4e06-a1ab-330816fac5e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameParagon Super Stim Electrode
Version Model Number2" x 2" Cloth Electrodes
Catalog Number442522
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
GS100866811000208 [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

Devices Manufactured by PARAGON REHAB SUPPLIES LLC

00866811000208 - Paragon Super Stim Electrode2018-07-06
00866811000208 - Paragon Super Stim Electrode2018-07-06
00866811000215 - Paragon Super Stim Electrodes2018-07-06
00866811000222 - Paragon Super Stim Electrodes2018-07-06
00866811000239 - Paragon Super Stim Electrodes2018-07-06

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