FDA.reportPublic FDA data

NeuroTherm™

Primary DI
05415067021342
Brand
NeuroTherm™
Company
NEUROTHERM, INC.
Model
AC-IDET-8
Catalog number
AC-IDET-8
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
05415067021342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067021342054150670213425415067021342

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
05415067021274NeuroTherm™AC-POLE-NTAC-POLE-NT2015-12-18
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
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
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06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
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06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
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06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
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06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501276APKAPK Technology Co.,Ltd.IKD2025-07-22