FDA.reportPublic FDA data

The Electrode Store

Primary DI
00816022022155
Brand
The Electrode Store
Company
IMPULSE MEDICAL TECHNOLOGIES, INC.
Model
PRO-EW
Catalog number
PRO-EG
Device description
".5"" SUBDERMALS(PKG/5) - GREEN"
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020910000SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAFThe Electrode Store, Inc.2002-07-19GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816022022155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816022022155008160220221558160220221550816022022155

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080015502
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816022023657DPNCheck NC-0302026-01-09
00816022023664DPNCheckNC-0402026-01-09
00816022023671DPNCheckNC-040-C2026-01-09
00816022023688DPNCheckNC-DP22026-01-09
00816022023695DPNCheckDB-025-Training2026-01-09
00816022023701DPNCheckDB-0502026-01-09
00816022023718DPNCheckDB-050-C2026-01-09
00816022023633The Electrode StorePRO-EE6XPRO-EE6X2024-07-15
00816022020786The Electrode StoreSDN1248SDN12482016-09-24
00816022020793The Electrode StoreSDN1280SDN12802016-09-24
00816022020809The Electrode StoreSDN1248BSDN1248B2016-09-24
00816022021226The Electrode StoreDEN-12SAFDEN-12SAF2016-09-24
00816022021233The Electrode StorePRO-E12SAFPRO-E12SAF2016-09-24
00816022022025The Electrode StorePRO-E3PRO-E32016-09-24
00816022022032The Electrode StorePRO-E5PRO-E52016-09-24
00816022022070The Electrode StorePRO-E4PRO-E42016-09-24
00816022022087The Electrode Store62056620562016-09-24
00816022022094The Electrode Store62057620572016-09-24
00816022022100The Electrode Store0048330048332016-09-24
00816022022117The Electrode StoreOBM00046OBM000462016-09-24

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