FDA.reportPublic FDA data

Tether Extension Cable Male-to-Male 3m

Primary DI
00850011306307
Brand
Tether Extension Cable Male-to-Male 3m
Company
NEURALYNX, INC.
Model
3 meter
Catalog number
31-0613-0031
Device description
The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110967000ENTERPRISE ELECTROPHYSIOLOGY SYSTEMNeuralynx, Inc.2011-06-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011306307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011306307008500113063078500113063070850011306307

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4065854542support@neuralynx.com

Regulatory Flags#

DUNS number
933200842
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011306314ATLAS Cart - Dual Monitors31-0605-016931-0605-01692026-04-27
00850011306291High Density Tether 7.5m7.5 meter31-0202-00072026-02-19
00850011306338ATLAS Stim Headbox - TouchproofTouchproof31-0601-00892025-06-11
00850011306345ATLAS Stim Headbox - High DensityHigh Density31-0601-01322025-06-11
00850011306703ATLAS Stim Headbox Software1.5.136-0301-00062025-06-11
00850011306710Fiber Optic Connector 2m2m31-0204-00012025-06-11
00850011306727Fiber Optic Connector 7m7m31-0204-00022025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofTouchproof31-0204-00042025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNK31-0204-00032025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityHigh Density31-0204-00052025-06-11
00867718000285ATLAS Stim Headbox - NKNK31-0601-00772025-06-11
00850011306512ATLAS Headbox Expansion PanelATLAS HEP31-0607-00142022-11-10
00850011306970Zipshield 8m8m31-0604-01292024-12-11
00850011306932ATLAS Workstation MonitorATLAS Workstation Monitor31-0000-00022024-12-18
00850011306949ATLAS WorkstationATLAS Workstation31-0004-00002024-12-18
00850011306956ATLAS Parallel TTL CableATLAS Parallel TTL Cable31-0602-00242024-12-18
00850011306239ATLAS Rackmounted Power IsolatorATLAS Rackmounted Power Isolator31-0607-00152024-12-11
00850011306253Ethernet SwitchEthernet Switch31-0604-01392024-12-11
00850011306963Zipshield 5m5m31-0604-01282024-12-11
00850011306987ATLAS Power Isolator 110VAC110VAC31-0607-00082024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13
08698870325334FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325341FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325358FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325365FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325372FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870328588FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870329523FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335708FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335715FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335722FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335739FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336446FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336453FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336460FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336477FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336484FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336491FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22