FDA.reportPublic FDA data

NA

Primary DI
00643169294394
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
8227422
Device description
ELECTRODE 8227422 TWIST PAIR ST 8CH ROHS
Published
2016-04-07
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
IKNElectromyograph, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical 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
00643169294394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169294394006431692943946431692943940643169294394

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000945817ApexCut EM187BL4012EM2026-10-24
00763000945824ApexCut EM187BL4040EM2026-10-24
00763000945831ApexCut EM187BL4060EM2026-10-24
00763000945848ApexCut EM187BL2975EM2026-10-24
00763000945855ApexCut EM187BL3590EM2026-10-24
00763000957858ApexCut EM187BL4000LEM2026-10-24
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
00763000886790N/aMEDTRONIC XOMED, INC.IKN2025-06-23
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
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
00195377153951PULSENuvasive, Inc.IKN2023-07-11
00195377153968PULSENuvasive, Inc.IKN2023-07-11
00195377153975PULSENuvasive, Inc.IKN2023-07-11
00195377060761PULSENuvasive, Inc.IKN2023-07-06
00195377060778PULSENuvasive, Inc.IKN2023-07-06
00195377153807PULSENuvasive, Inc.IKN2023-05-02
00195377153814PULSENuvasive, Inc.IKN2023-05-02
00195377083272NVM5Nuvasive, Inc.IKN2023-04-13
00195377097415NVM5Nuvasive, Inc.IKN2023-04-13
00195377097422NVM5Nuvasive, Inc.IKN2023-04-13
00195377097439NVM5Nuvasive, Inc.IKN2023-04-13
00190376458601SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00190376459035SafeOpALPHATEC SPINE, INC.IKN2023-02-12
04250307601424ISISinomed Medizintechnik GmbHIKN2022-09-16
04250307607280ISISinomed Medizintechnik GmbHIKN2022-09-16
04250307607297ISISinomed Medizintechnik GmbHIKN2022-09-16
04250307607440ISISinomed Medizintechnik GmbHIKN2022-09-05