Corkscrew Electrode

Primary DI
00852373007212
Brand
Corkscrew Electrode
Company
SGM d.o.o.
Model
003-400001-5
Catalog number
003-400001-5
Device description
Corkscrew electrode CS-F (2m) 003-400001-5. Five 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
Rx
false
OTC
false
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
00852373007205PackageGS1300In Commercial Distribution
00852373007212PackageGS1350In Commercial Distribution
00852373007267PackageGS12Not in Commercial Distribution
00852373007274PackageGS1100In Commercial Distribution
00852373007199PrimaryGS10
00852373007045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852373007205008523730072058523730072050852373007205
00852373007212008523730072128523730072120852373007212
00852373007267008523730072678523730072670852373007267
00852373007274008523730072748523730072740852373007274
00852373007199008523730071998523730071990852373007199
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
499490357
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852373007199Corkscrew Electrode003-400001-5003-400001-52018-03-23
00852373007229Corkscew Electrode003-400001-4003-400001-42018-03-23
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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