FDA.reportPublic FDA data

N/a

Primary DI
20763000886794
Brand
N/a
Company
MEDTRONIC XOMED, INC.
Model
9626340
Device description
ELECTRODE 9626340 10PK TWIST PAIR ROHS
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
20763000886794PackageGS110In Commercial Distribution
00763000886790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300088679420763000886794
00763000886790007630008867907630008867900763000886790

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
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
false
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
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
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

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
00195377108128PULSENuvasive, Inc.IKN2022-06-30
00195377108135PULSENuvasive, Inc.IKN2022-06-30
00195377049131PULSENuvasive, Inc.IKN2022-05-06
00195377049148PULSENuvasive, Inc.IKN2022-05-06