SuperStim Electrodes

GUDID 80092237900211

SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam)

Compass Richmar, LLC

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device ID80092237900211
NIH Device Record Keyfed3637e-d494-4c80-b8b8-b8b4d5bef083
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperStim Electrodes
Version Model Number400-857
Company DUNS080930531
Company NameCompass Richmar, LLC
Device Count4
DM Exemptfalse
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

Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100092237900215 [Primary]
GS101092237900214 [Unit of Use]
GS130092237900216 [Package]
Contains: 00092237900215
Package: Inner Carton [10 Units]
In Commercial Distribution
GS180092237900211 [Package]
Contains: 30092237900216
Package: Master Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-20

On-Brand Devices [SuperStim Electrodes]

80092237900334SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Cloth)
30092237900322SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam)
80092237900310SuperStim 3cm (1.25") Round (Foam)
80092237900303SuperStim 3cm (1.25") Round (Cloth)
80092237900297SuperStim 7.6cm (3") Round (Foam)
80092237900280SuperStim 7.6cm (3") Round (Cloth)
80092237900273SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam)
80092237900266SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth)
80092237900259SuperStim 5cmx5cm(2"x2") Square (Foam)
80092237900242SuperStim 5cmx5cm(2"x2") Square (Cloth)
80092237900235SuperStim 5cm (2") Round (Foam)
80092237900228SuperStim 5cm (2")Round (Cloth)
80092237900211SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam)
30092237900209SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth)
80092237900198SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam)
80092237900181SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth)
00853904006988SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam), Case of 10
00853904006971SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth), Case of 10
00853904006964SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam), Case of 10
00853904006957SuperStim 7.6cm x 13cm (2" x 3.5") Rectangle (Cloth)*, Case of 10
00853904006940SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam), Case of 10
00853904006933SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth), Case of 10
00853904006926SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam), Case of 10
00853904006919SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth), Case of 10
00853904006902SuperStim 3cm (1.25") Round (Foam), Case of 10
00853904006896SuperStim 3cm (1.25") Round (Cloth), Case of 10
00853904006889SuperStim 7.6cm (3") Round (Foam), Case of 10
00853904006858SuperStim 7.6cm (3") Round (Cloth), Case of 10
00853904006735SuperStim 5cmx5cm(2"x2") Square (Foam), Case of 10
00853904006728SuperStim 5cmx5cm(2"x2") Square (Cloth), Case of 10
00853904006711SuperStim 5cm (2") Round (Foam), Case of 10
00853904006704SuperStim 5cm (2")Round (Cloth), Case of 10
00853904006568SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam)
00853904006551SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth)
00853904006544SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam)
00853904006537SuperStim 7.6cm x 13cm (2" x 3.5") Rectangle (Cloth)
00853904006520SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam)
00853904006513SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth)
00853904006506SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam)
00853904006490SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth)
00853904006483SuperStim 3cm (1.25") Round (Foam)
00853904006476SuperStim 3cm (1.25") Round (Cloth)
00853904006469SuperStim 7.6cm (3") Round (Foam)
00853904006452SuperStim 7.6cm (3") Round (Cloth)
00853904006445SuperStim 5cmx5cm(2"x2") Square (Foam)
00853904006438SuperStim 5cmx5cm(2"x2") Square (Cloth)
00853904006421SuperStim 5cm (2") Round (Foam)
00853904006414SuperStim 5cm (2")Round (Cloth)
008532790070473" x 5" Rectagulo (Hule)
00850958007510SuperStim 7.6cm x 13cm (3"x5") Rectangle (Cloth)

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