Twisted Pair Needle Electrode

Primary DI
00852373007083
Brand
Twisted Pair Needle Electrode
Company
SGM d.o.o.
Model
003-400124-3
Catalog number
003-400124-3
Device description
Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.
Published
2016-09-23
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
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010019000STERILE SUBDERMAL NEEDLE ELECTRODESNicolet Biomedical, Inc.2001-03-19GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852373007090PackageGS1250In Commercial Distribution
00852373007144PackageGS1350In Commercial Distribution
00852373007151PackageGS1100In Commercial Distribution
00852373007175PackageGS1300In Commercial Distribution
00852373007083PrimaryGS10
00852373007076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852373007090008523730070908523730070900852373007090
00852373007144008523730071448523730071440852373007144
00852373007151008523730071518523730071510852373007151
00852373007175008523730071758523730071750852373007175
00852373007083008523730070838523730070830852373007083
00852373007076008523730070768523730070760852373007076

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Meter
Length12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
499490357
Device count
3
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
00852373007229Corkscew Electrode003-400001-4003-400001-42018-03-23
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

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