Eagle Electrode Manufacturing Self Adhering Electrodes

Primary DI
00867991000224
Brand
Eagle Electrode Manufacturing Self Adhering Electrodes
Company
EAGLE ELECTRODE MANUFACTURING LLC
Model
EEM3RND
Catalog number
EEM3RND
Device description
3 inch round electrodes for use with TENS, NMES, IFC, EMG devices
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030800000ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODESEletromed, Inc.2003-06-11GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867991000224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867991000224008679910002248679910002240867991000224

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-486-3332eric.reifer@eagleelectrode.com

Regulatory Flags#

DUNS number
071834627
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867991000200Eagle Electrode Manufacturing Self Adhering ElectrodesEEM2X2SEEM2X2S2016-08-19
00867991000217Eagle Electrode Manufacturing Self Adhering ElectrodesEEM2RNDEEM2RND2016-08-19
00867991000231Eagle Electrode Manufacturing Self Adhering ElectrodesEEM2X4RCTEEM2X4RCT2016-08-19

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Primary DI, Brand, Company table
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