FDA.reportPublic FDA data

The Electrode Store

Primary DI
00816022020809
Brand
The Electrode Store
Company
IMPULSE MEDICAL TECHNOLOGIES, INC.
Model
SDN1248B
Catalog number
SDN1248B
Device description
"Intraoperative Needle Electrodes, Subdermal 12mmX 29 ga, 48"" Braided Wires"
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
00816022020809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816022020809008160220208098160220208090816022020809

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
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
00816022022124The Electrode StorePRO-EYPRO-EY2016-09-24

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