Corkscew Electrode

Primary DI
00852373007243
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
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
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
499490357
Device count
4
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
00852373007212Corkscrew Electrode003-400001-5003-400001-52018-03-23
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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