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
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G012BRCA02BioStamp® nPointMedidata Solutions, Inc.IKN2021-04-01
G012BRCA05BioStamp®Medidata Solutions, Inc.IKN2021-04-01
G012BRCD02BioStamp®Medidata Solutions, Inc.IKN2021-04-01
G012BRCP01BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012BRCP02BioStamp® nPointMedidata Solutions, Inc.IKN2021-04-01
G012BRCP03BioStamp®Medidata Solutions, Inc.IKN2021-04-01
G012BRCS02BioStamp®Medidata Solutions, Inc.IKN2021-04-01
G012BRCT01BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012BSPS01BioStamp®Medidata Solutions, Inc.IKN2021-04-01
G012MC0003BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0004BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0005BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0006BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0007BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0008BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0012BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0013BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0014BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012MC0015BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012SW0025BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012SW0026BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01
G012SW0027BioStamp nPoint™Medidata Solutions, Inc.IKN2021-04-01