Corkscew Electrode

Primary DI
00852373007229
Brand
Corkscew Electrode
Company
SGM d.o.o.
Model
003-400001-4
Catalog number
003-400001-4
Device description
Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double package to preserve sterility of the product. Use for one medical operation.
Published
2018-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934779000AGRAM SPYRAL ELECTRODEAgram Export-Import Co.1995-03-14GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852373007236PackageGS1300In Commercial Distribution
00852373007243PackageGS1350In Commercial Distribution
00852373007250PackageGS12In Commercial Distribution
00852373007281PackageGS1100In Commercial Distribution
00852373007229PrimaryGS10
00852373007045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852373007236008523730072368523730072360852373007236
00852373007243008523730072438523730072430852373007243
00852373007250008523730072508523730072500852373007250
00852373007281008523730072818523730072810852373007281
00852373007229008523730072298523730072290852373007229
00852373007045008523730070458523730070450852373007045

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Meter

Contacts#

Phone, Email table
PhoneEmail
4049445709suzy.simic@medical-electrodes.com

Regulatory Flags#

DUNS number
499490357
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852373007199Corkscrew Electrode003-400001-5003-400001-52018-03-23
00852373007212Corkscrew Electrode003-400001-5003-400001-52018-03-23
00852373007243Corkscew Electrode003-400001-4003-400001-42018-03-23
00852373007021Corkscrew Electrode 003-400000-6 003-400000-62016-09-23
00852373007052Corkscrew Electrode 003-400001-6003-400001-62016-09-23
00852373007083Twisted Pair Needle Electrode 003-400124-3003-400124-32016-09-23

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