FDA.reportPublic FDA data

N/A

Primary DI
20763000038261
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
8227510
Device description
ELECTRODE 8227510 5PK PR 2CH18MM 2M ROHS
Published
2019-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZELECTRODE, NEEDLE
IKNElectromyograph, diagnostic
IKTElectrode, needle, diagnostic electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024316000NIM-PRSMedtronic Xomed, Inc.2003-01-06IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000038261PackageGS15In Commercial Distribution
00763000038267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300003826120763000038261
00763000038267007630000382677630000382670763000038267

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15
00643169644830Otomag™ Attract™ Magnetic SpacerS0542-042016-04-15
00643169644847Otomag™ Attract™ Magnetic SpacerS0542-052016-04-15
00643169644854Otomag™ Attract™ Magnetic SpacerS0542-062016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869277AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869307AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869338AmbuTechnomed Engineering B.V.GXZ2022-07-04