FDA.reportPublic FDA data

NeuroTherm™

Primary DI
05415067021274
Brand
NeuroTherm™
Company
NEUROTHERM, INC.
Model
AC-POLE-NT
Catalog number
AC-POLE-NT
Device description
Adapter Cable
Published
2015-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGenerator, lesion, radiofrequency
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067021274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067021274054150670212745415067021274

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place; avoid exposure to extreme temperatures.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
124023552
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067021243NeuroTherm™AC-B-DUKAC-B-DUK2015-12-18
05415067021342NeuroTherm™AC-IDET-8AC-IDET-82015-12-18
05415067022936NeuroTherm™S-1010-B-18S-1010-B-182015-09-14
05415067022943NeuroTherm™S-1510-B-18S-1510-B-182015-09-14
05415067021922NeuroTherm™CLASSICS-1520-RP2015-09-14
05415067021939NeuroTherm™CLASSICS-2020-RP2015-09-14
05415067022295NeuroTherm™CLASSICC-1010-B2015-09-14
05415067022448NeuroTherm™CLASSICS-1510-182015-09-14
05415067026576NeuroTherm™PT-KIT-SPT-KIT-S2016-09-12
05415067021571NeuroTherm™RFDE-10RFDE-102015-10-30
05415067021588NeuroTherm™RFDE-15RFDE-152015-10-30
05415067022349NeuroTherm™RFDEUK-15RFDEUK-152015-10-30
05415067022363NeuroTherm™RFDEUK-20RFDEUK-202015-10-30
05415067022394NeuroTherm™RFDEUK-5RFDEUK-52015-10-30
05415067021137NeuroTherm™NRFE-10NRFE-102015-10-30
05415067021144NeuroTherm™NRFE-15NRFE-152015-10-30
05415067021151NeuroTherm™NRFE-5NRFE-52015-10-30
05415067021595NeuroTherm™RFDE-5RFDE-52015-10-30
05415067021168NeuroTherm™RFE-10RFE-102015-10-30
05415067021175NeuroTherm™RFE-10-SRFE-10-S2015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08698870336507FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336514FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336521FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336538FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336545FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22